Instrumentation Laboratory CO
Medical device manufacturer in Bedford, MA.
326510(k) clearances
0PMA approvals
95recalls
Device types
- GGP Test, Qualitative And Quantitative Factor… 28
- CHL Electrode Measurement, Blood-Gases (Pco2… 16
- JPA System, Multipurpose For In Vitro… 12
- GJS Test, Time, Prothrombin 11
- DAP Fibrinogen And Fibrin Split Products… 10
- GJT Plasma, Coagulation Factor Deficient 10
- CGA Glucose Oxidase, Glucose 9
- GKP Instrument, Coagulation, Automated 9
- JBQ Antithrombin Iii Quantitation 9
- GGN Plasma, Coagulation Control 8
- KFF Assay, Heparin 6
- JXR Atomic Absorption Spectrophotometer… 5
- JQP Calculator/Data Processing Module, For… 5
- JGS Electrode, Ion Specific, Sodium 5
- GFO Activated Partial Thromboplastin 4
- JIX Calibrator, Multi-Analyte Mixture 4
- GKL Counter, Cell, Automated (Particle Counter) 4
- JJQ Colorimeter, Photometer, Spectrophotometer… 4
- CFR Hexokinase, Glucose 3
- DKB Calibrators, Drug Mixture 3
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
| K203790 | GEM Premier 5000CHL · Special | 08/20/2021SE |
| K200033 | HemosIL von Willebrand Factor AntigenGGP · Special | 08/19/2020SE |
| K183555 | GEM Premier ChemSTATJFY · Traditional | 02/16/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | 02/16/2019SE |
| K183546 | GEM Premier ChemSTATCGA · Traditional | 02/16/2019SE |
| K180486 | HemosIL Factor XII Deficient PlasmaGJT · Special | 03/22/2018SE |
| K173403 | GEM Premier 5000CHL · Traditional | 12/29/2017SE |
| K172903 | HemosIL D-Dimer HS 500DAP · Special | 11/22/2017SE |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsLCO · Traditional | 09/08/2017SE |
| K170314 | ACL AcuStarJPA · Special | 03/03/2017SE |
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…GKF · Traditional | 12/14/2016SE |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)CHL · Traditional | 12/14/2016SE |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)CGA · Traditional | 12/14/2016SE |
| K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…JGS · Traditional | 12/14/2016SE |
| K160885 | HemosIL D-Dimer HSDAP · Special | 10/27/2016SE |
| K161818 | GEM Premier 3000CGA · Special | 09/14/2016SE |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsLCO · Traditional | 07/08/2016SE |
| K160445 | HemosIL Silica Clotting TimeGFO · Special | 03/16/2016SE |
| K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)GKP · Special | 03/03/2016SE |
| K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…GKP · Traditional | 12/13/2015SE |
| K151534 | HemosIL D-Dimer HSDAP · Special | 07/06/2015SE |
| K133582 | Hemosil D-Dimer HS 500 ControlGGN · Traditional | 08/15/2014SE |
| K133005 | Hemosil Von Willebrand Activity AssayGGP · Special | 03/13/2014SE |
| K132722 | Hemosil Recombiplastin 2G (8 ML Vial)GJS · Special | 01/22/2014SE |
| K133407 | Gem Premier 4000CHL · Special | 01/13/2014SE |
| K122584 | Hemosil Readiplas TinGJS · Traditional | 03/24/2013SE |
| K112995 | Gem Premier 4000CEM · Traditional | 05/03/2012SE |
| K113211 | Hemosil la Positive Control & Hemosil la Negative ControlGGN · Traditional | 01/04/2012SE |
| K110031 | Hemosil Drvvt Screen & Hemosil Drvvt ConfirmGIR · Traditional | 08/24/2011SE |
| K110237 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | 07/08/2011SE |
| K102552 | Hemosil la Positive ControlGGC · Traditional | 04/05/2011SE |
| K102164 | Hemosil Protein S Activity AssayGGP · Traditional | 03/17/2011SE |
| K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…CIG · Traditional | 06/18/2010SE |
| K091556 | Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsMSV · Traditional | 05/21/2010SE |
| K093737 | Hemosil F11 & FV DNA ControlNZB · Traditional | 05/04/2010SE |
| K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsMID · Traditional | 03/11/2010SE |
| K090264 | Hemosil D-Dimer HS 500, ControlsDAP · Traditional | 02/05/2010SE |
| K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)GGN · Traditional | 10/09/2009SE |
| K091980 | Acl Top 700 LasGKP · Special | 09/22/2009SE |
| K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and Uf Heparin ControlsKFF · Traditional | 06/02/2009SE |
| K083518 | Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsJPA · Traditional | 03/13/2009SE |
| K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedGGN · Traditional | 12/19/2008SE |
| K073042 | Hemosil D-DimerDAP · Traditional | 07/31/2008SE |
| K073377 | Acl Top (with System Software V3.0.0)GKP · Traditional | 05/04/2008SE |
| K073367 | Hemosil Fibrinogen-CKQJ · Special | 12/27/2007SE |
| K070927 | Hemosil D-Dimer HSDAP · Traditional | 09/17/2007SE |
| K070005 | Hemosil Recombiplastin 2GGJS · Traditional | 08/15/2007SE |
| K070635 | Hemosil ProclotGGP · Special | 03/29/2007SE |
| K070301 | Hemosil AntithrombinJBQ · Special | 02/23/2007SE |
| K063679 | Acl TopGKP · Special | 01/12/2007SE |
| K061598 | Hemosil Homocysteine and ControlsLPS · Traditional | 09/22/2006SE |
| K061974 | Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with Co-Ox; Gem CVP 3 and 4…CHL · Traditional | 09/15/2006SE |
| K062431 | Hemosil Liquid AntithrombinJBQ · Special | 09/01/2006SE |
| K062430 | Hemosil Protein CGGP · Special | 09/01/2006SE |
| K060931 | Hemosil Pt-Fibrinogen HS PlusGJS · Special | 05/02/2006SE |
| K060688 | Hemosil SynthasilGFO · Special | 04/13/2006SE |
| K060162 | Acl Elite; Acl Elite ProJPA · Special | 02/21/2006SE |
| K053499 | Hemosil ProsGGP · Special | 01/13/2006SE |
| K052121 | Gem Premier 3000CGA · Special | 10/21/2005SE |
| K050661 | Hemosil Factor II Deficient PlasmaGJT · Traditional | 05/02/2005SE |
| K050544 | Hemosil D-Dimer HSDAP · Traditional | 04/26/2005SE |
| K050221 | Hemosil Silica Clotting TimeGFO · Traditional | 03/30/2005SE |
| K050278 | Hemosil D-DimerDAP · Traditional | 03/10/2005SE |
| K043459 | Hemosil Factor Xii Deficient PlasmaGJT · Traditional | 02/09/2005SE |
| K043184 | Hemosil RecombiplastinGJS · Special | 12/22/2004SE |
| K042982 | Quantex MyoglobinDDR · Traditional | 12/22/2004SE |
| K042576 | Coatest SP FviiiGGP · Traditional | 12/02/2004SE |
| K041905 | Hemosil Calibration PlasmaJIX · Traditional | 09/28/2004SE |
| K040879 | Quantex FerritinDBF · Traditional | 05/10/2004SE |
| K040843 | Hemosil Von Willebrand ActivityGGP · Traditional | 04/30/2004SE |
| K040359 | Hemosil Special Test Controls Level 1 & 2JPA · Traditional | 03/19/2004SE |
| K034007 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | 02/13/2004SE |
| K033414 | Acl Top Model, TopGKP · Abbreviated | 01/12/2004SE |
| K033775 | Hemosil Liquid Antithrombin XLJBQ · Special | 01/02/2004SE |
| K032663 | Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls…DCK · Traditional | 12/19/2003SE |
| K033631 | Modification to Coatest Factor ViiiGGP · Special | 12/15/2003SE |
| K032419 | Quantex D-DimerDAP · Traditional | 10/24/2003SE |
| K031829 | Hemosil Factor Ix Deficient PlasmaGJT · Traditional | 07/31/2003SE |
| K030965 | Control Plasma LMW HeparinGGN · Traditional | 06/06/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | 06/06/2003SE |
| K031122 | Hemosil Factor X Deficient PlasmaGJT · Traditional | 05/19/2003SE |
| K030287 | Hemosil Factor Xi Deficient PlasmaGJT · Traditional | 03/19/2003SE |
| K030215 | Biorapid MononucleosisKTN · Traditional | 02/24/2003SE |
| K024082 | Hemosil Factor Vii Deficient PlasmaGJT · Traditional | 02/12/2003SE |
| K023839 | Hemosil Factor V Deficient PlasmaGJT · Traditional | 01/14/2003SE |
| K023269 | Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity ControlsDCK · Traditional | 12/23/2002SE |
| K022158 | Iqm (Intelligent Quality Management) on the Gem Premier 3000, CVP (Calibration…CGA · Traditional | 09/10/2002SE |
| K022550 | Coamatic LR Antithrombin, Note: Lr=Liquid ReagentsJBQ · Traditional | 08/27/2002SE |
| K022195 | Coamatic AT-400JBQ · Traditional | 08/07/2002SE |
| K021024 | Hemosil High Abnormal Control AssayedGGN · Traditional | 05/16/2002SE |
| K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)GGN · Traditional | 05/14/2002SE |
| K021022 | Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)GGN · Traditional | 05/14/2002SE |
| K012901 | Color-MonogenKTN · Traditional | 09/27/2001SE |
| K012768 | Hemosil Recombi PlastinGJS · Traditional | 09/18/2001SE |
| K011424 | Il Test ProsGGP · Traditional | 06/25/2001SE |
| K010520 | Gem Premier 3000- Addition of Glucose and Lactate AS New ParametersCGA · Traditional | 05/07/2001SE |
| K010379 | Il Test Free Protein SGGP · Traditional | 04/13/2001SE |
| K002467 | Coaliza Protein S-FreeGGP · Traditional | 10/13/2000SE |
| K002400 | Modification of Acl AdvanceJPA · Special | 08/30/2000SE |
| K994238 | Il Test Liquid AntithrombinJBQ · Traditional | 06/23/2000SE |
| K000053 | Acl 9000 SystemJPA · Traditional | 03/15/2000SE |
| K992834 | Gem Premier 3000CHL · Traditional | 11/24/1999SE |
| K992704 | Il Test Von Willebrand FactorGGP · Traditional | 11/01/1999SE |
| K990302 | Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to…GIR · Traditional | 04/08/1999SE |
| K984437 | Quantex Aso-Crp-Rp Control IIJJT · Traditional | 02/02/1999SE |
| K983178 | Coamatic HeparinKFF · Traditional | 11/03/1998SE |
| K981817 | Coamatic Plasmin InhibitorGGP · Traditional | 09/28/1998SE |
| K981696 | Il Test Plasmin InhibitorGGP · Traditional | 08/27/1998SE |
| K981263 | ToxogenGMM · Traditional | 08/06/1998SE |
| K981479 | Il Test Pt-Fibrinogen RecombinantGJS · Traditional | 07/07/1998SE |
| K981200 | Il Test PlasminogenGGP · Traditional | 05/26/1998SE |
| K980646 | Il Synthesis--Addition of Bilirubin AS a Measured Parameter for Neonate Whole Blood…MQM · Traditional | 05/06/1998SE |
| K974711 | Coamatic PlasminogenGGP · Traditional | 05/01/1998SE |
| K974456 | CmvgenLJO · Traditional | 05/01/1998SE |
| K980875 | Il Test Protein CGGP · Traditional | 04/21/1998SE |
| K980757 | Ilab 600 Clinical Chemistry SystemCGZ · Traditional | 04/21/1998SE |
| K981038 | Coamatic Factor ViiiGGP · Traditional | 04/16/1998SE |
| K980499 | Il Test AntithrombinJBQ · Traditional | 04/02/1998SE |
| K980242 | Il Test HeparinKFF · Traditional | 03/19/1998SE |
| K974337 | Il Test Urea NitrogenCDQ · Traditional | 12/17/1997SE |
| K974125 | Il Test AmylaseJFJ · Traditional | 12/17/1997SE |
| K973306 | Il Test Aptt-SpGFO · Traditional | 11/04/1997SE |
| K972696 | Il Test D-DimerDAP · Traditional | 11/04/1997SE |
| K973464 | Quantex RF Plus (Latex, Buffer, Standard, Control)DHR · Traditional | 10/22/1997SE |
| K972861 | Il Test Contril Spectrum (Levels 1, 2 and 3)JJS · Traditional | 08/19/1997SE |
| K972363 | Il Test IronJIY · Traditional | 08/15/1997SE |
| K971777 | Quantex Aso-Crp-Rf ControlJJT · Traditional | 05/27/1997SE |
| K963800 | Il SynthesisCHL · Traditional | 11/13/1996SE |
| K962202 | Quantex IggDEW · Traditional | 09/26/1996SE |
| K962198 | Quantex C4DBI · Traditional | 09/26/1996SE |
| K962201 | Quantex IgmDFT · Traditional | 09/25/1996SE |
| K962200 | Quantex IgaCZP · Traditional | 09/25/1996SE |
| K962199 | Quantex C3CZW · Traditional | 09/25/1996SE |
| K961991 | Acl 6000 System (Acl 6000)GKP · Traditional | 09/04/1996SE |
| K955793 | Il Bgge Blood Gas with Glucose SystemCHL · Traditional | 02/14/1996SE |
| K943367 | Il Test CholinesteraseDIH · Traditional | 02/05/1996SE |
| K943366 | Il Test Acid PhosphataseCKB · Traditional | 01/29/1996SE |
| K951891 | Acl Futura Coagulation SystemJPA · Traditional | 11/03/1995SE |
| K945677 | IL682, Co-OximeterGKR · Traditional | 10/20/1995SE |
| K952646 | Il Test Ck-MbCGS · Traditional | 08/04/1995SE |
| K952647 | Il Test LipaseCHI · Traditional | 07/20/1995SE |
| K951391 | Il Test Digoxin, PN 181761-00KXT · Traditional | 06/09/1995SE |
| K943686 | Il Test BETA-2MICROGLOBULINJZG · Traditional | 05/15/1995SE |
| K943980 | Il Test Phenytion CalibratorsDIP · Traditional | 05/01/1995SE |
| K943983 | Il Test Digoxin & Il Test Digoxin CalibratorsKXT · Traditional | 04/10/1995SE |
| K943982 | Il Test Gentamicin CalibratorsLCD · Traditional | 01/25/1995SE |
| K942687 | Il Test Carbamazepine, PN 181754-00; Il Test Carbamazepine Calibrators, PN 181762-00KLT · Traditional | 01/25/1995SE |
| K943981 | Il Test Phenobarbital CalibratorsDLZ · Traditional | 01/18/1995SE |
| K943979 | Il Test TheophyllineKLS · Traditional | 01/18/1995SE |
| K943595 | Serum/Urine Appli Ilab(Tm) Clinical Chemistry SystemJJQ · Traditional | 11/28/1994SE |
| K931118 | Assess(Tm) High Abnormal ControlGJS · Traditional | 03/30/1994SE |
| K931117 | Assess(Tm) Low Abnormal ControlGJS · Traditional | 03/30/1994SE |
| K935069 | IL1430 Bgelectrolyte AnalyzerCHL · Traditional | 03/28/1994SE |
| K931116 | Il Test(Tm) TriglycerideJGY · Traditional | 03/28/1994SE |
| K935212 | Il Test Heparin (Xa), PN 84699-15KFF · Traditional | 02/07/1994SE |
| K931362 | Il Test CalciumCIC · Traditional | 02/01/1994SE |
| K932467 | Ilab 900/1800 Clinical Chemistry SystemJJQ · Traditional | 11/05/1993SE |
| K931402 | Il Test GlucoseCFR · Traditional | 10/12/1993SE |
| K933252 | Il Test (TM) Pt-Fibrinogen HS PlusGJS · Traditional | 10/04/1993SE |
| K933684 | Il Test CarbamazephineKLT · Traditional | 10/01/1993SE |
| K931350 | Il Test Uric AcidKNK · Traditional | 10/01/1993SE |
| K931721 | Il Test Fibrinogen-CKQJ · Traditional | 08/13/1993SE |
| K924098 | Il MCL-2 Coagulation AnalyzerGKP · Traditional | 06/18/1993SE |
| K931361 | Il Test PhosphorusCEO · Traditional | 05/11/1993SE |
| K930327 | Il Test(Tm) Protein SGGP · Traditional | 04/12/1993SE |
| K923079 | Il Test Calibration Set Apo A1BDFC · Traditional | 02/05/1993SE |
| K924884 | Il Test(Tm) Pro-ChromGGP · Traditional | 01/14/1993SE |
| K923921 | Il Test PT Fibrinogen HSGIS · Traditional | 10/26/1992SE |
| K923641 | Il Test Ast, PN 35312CIT · Traditional | 10/26/1992SE |
| K923087 | Il Test Apolipoprotein A1MSJ · Traditional | 10/26/1992SE |
| K923080 | Il Test Apoliporotein B (Apo B)MSJ · Traditional | 10/26/1992SE |
| K922532 | Il Test Glucose, PN 181633-80CGA · Traditional | 09/30/1992SE |
| K923623 | Il Test Alt, PN 35311CKA · Traditional | 09/17/1992SE |
| K920012 | Il Test(Tm) ALPHA-2-ANTIPLASMIN Assay SystemGGP · Traditional | 08/12/1992SE |
| K920005 | Il Test ALPHA-1-ANTITRYPSIN (Aat)DEM · Traditional | 07/29/1992SE |
| K915829 | Il Test(Tm) Haptoglobin (HPT)DAD · Traditional | 07/29/1992SE |
| K920653 | Il Test Bilirubin Total/DirectCIG · Traditional | 07/23/1992SE |
| K920014 | Il Test Immunoglobulin aCZP · Traditional | 06/16/1992SE |
| K920007 | Il Test Complement 3CZW · Traditional | 06/16/1992SE |
| K920858 | Il Test MethadoneDJR · Traditional | 04/24/1992SE |
| K920417 | Il Test Barbiturate, 35289DIS · Traditional | 04/24/1992SE |
| K920010 | Il Test Complement 4DBI · Traditional | 03/13/1992SE |
| K920006 | Il Test Immunoglobulin G (Igg)CGM · Traditional | 03/13/1992SE |
| K920419 | Il Test Dat Cal/Control Set D/EDLG · Traditional | 03/11/1992SE |
| K920008 | Il Test Immunoglobulin M (Igm)CGM · Traditional | 03/11/1992SE |
| K914877 | Il Test(Tm) Urea NitrogenCDQ · Traditional | 03/11/1992SE |
| K920418 | Il Test Cannabinoid, 35282LDJ · Traditional | 02/27/1992SE |
| K913744 | Il Test(Tm) AmlylaseJFJ · Traditional | 02/18/1992SE |
| K914815 | Il Test(Tm) BenzodiazepineJXM · Traditional | 01/27/1992SE |
| K914909 | Il Test(Tm) Calibration Set SPJIX · Traditional | 01/22/1992SE |
| K914993 | Il Test(Tm) Transferrin (TRF)DDG · Traditional | 01/17/1992SE |
| K914811 | Il Test(Tm) HDL CholesterolLBR · Traditional | 01/09/1992SE |
| K913737 | Il Test(Tm) CocaineJXO · Traditional | 12/03/1991SE |
| K914151 | Il Test(Tm DigoxinKXT · Traditional | 11/29/1991SE |
| K913743 | Il Test(Tm) PhencyclidineLCM · Traditional | 11/07/1991SE |
| K913742 | Il Test(Tm) OpiateDJG · Traditional | 11/07/1991SE |
| K913738 | Il Test(Tm) AmphetamineDKZ · Traditional | 11/07/1991SE |
| K913741 | Il Test(Tm) Dat Cal/Control Set CDKB · Traditional | 10/21/1991SE |
| K913740 | Il Test(Tm) Dat Cal/Control Set BDKB · Traditional | 10/21/1991SE |
| K913927 | Il BG3 Syst, Model 1420, Blood Gas & PH Test SystCHL · Traditional | 10/11/1991SE |
| K912711 | Il Test Proclot Assay StystemGGP · Traditional | 10/09/1991SE |
| K912087 | Acl Coagulation Systems,Models 1000,2000,3000,PLUSJPA · Traditional | 09/19/1991SE |
| K913739 | Il Test(Tm) Dat Calibrator a( -)DKB · Traditional | 09/10/1991SE |
| K912016 | Il Phoenix(Tm), Model 905 Chem/Elect AnalyzerJGS · Traditional | 06/10/1991SE |
| K910697 | Il Theophylline Assay SystemKLS · Traditional | 04/03/1991SE |
| K910355 | Il Phenobarbital Assay SystemDLZ · Traditional | 04/03/1991SE |
| K904761 | P/N 35310, Il Test Alkaline Phosphatase ReagentCIE · Traditional | 11/20/1990SE |
| K903396 | Il T Uptake Assay SystemKHQ · Traditional | 10/12/1990SE |
| K903743 | Il Gentamicin Assay SystemLCD · Traditional | 09/17/1990SE |
| K903095 | Il Thyroxine (T4) Assay SystemKLI · Traditional | 08/23/1990SE |
| K903192 | Il Tobramycin AssayKLB · Traditional | 08/22/1990SE |
| K902952 | Il Phenytoin Assay SystemDIP · Traditional | 08/22/1990SE |
| K894852 | Serachem Plus Clinical Chemistry ControlsJJY · Traditional | 09/28/1989SE |
| K890827 | IL1400, Bgelectrolyte AnalyzerCHL · Traditional | 06/20/1989SE |
| K884771 | Il Phoenix, Model 900, Chemistry/Electrolyte AnalyJFP · Traditional | 02/10/1989SE |
| K881367 | Acl Systems 100, 200, 300 and 300+ Coagulation SysJPA · Traditional | 06/27/1988SE |
| K874763 | Cellect Model D, Automated Hemtalogy AnalyzerGKZ · Traditional | 02/18/1988SE |
| K874320 | Cellect Labtrak SoftwareGKL · Traditional | 01/27/1988SE |
| K873572 | Il 35260, Il Test Amylase ReagentCIJ · Traditional | 10/20/1987SE |
| K871973 | Il Monarch 1000 Clinical Chemistry Analytical Sys.JJG · Traditional | 06/11/1987SE |
| K871664 | Iron & Magnesium Additions/Referril B CalibratorJIX · Traditional | 05/08/1987SE |
| K864480 | Il Test 84668-15, Factor Viii Control PlasmaGGP · Traditional | 01/21/1987SE |
| K864497 | Coagulation Extrinsic Deficient PlasmasGGP · Traditional | 01/05/1987SE |
| K864481 | Coagulation Intrinsic Deficient PlasmasGGP · Traditional | 01/05/1987SE |
| K864211 | Il Test 97575-15, Heparin AssayKFF · Traditional | 01/05/1987SE |
| K864212 | Il Test 97573-15, Plasminogen AssayDDX · Traditional | 12/04/1986SE |
| K864271 | Il Test 84673-30 Chromogenics Control PlasmaJPA · Traditional | 11/25/1986SE |
| K864214 | Il Test 97574-15M, Antitthrombin III AssasyJBQ · Traditional | 11/25/1986SE |
| K864213 | Il Test 97572-15, Alpha 2-ANTIPLASMIN AssayLGP · Traditional | 11/25/1986SE |
| K863291 | Il Cellect 8GKL · Traditional | 09/04/1986SE |
| K863290 | Il Cellect 7GKL · Traditional | 09/04/1986SE |
| K862374 | Cellect 8E Automated Blood Cell CountersGKL · Traditional | 09/04/1986SE |
| K862301 | Il System 810, Acl and the Reagent SetsGJA · Traditional | 09/03/1986SE |
| K862253 | Il 482 Co-OximeterJKS · Traditional | 07/29/1986SE |
| K860097 | Therapeutic Drug (TDM) CalibratorDIF · Traditional | 02/11/1986SE |
| K844586 | Il Genesis 21, Clinical Chemistry Analytical SysJJF · Traditional | 12/11/1984SE |
| K844585 | Referril CalibratorsJIX · Traditional | 12/11/1984SE |
| K841736 | Il Test Antithrombin III ActivityJBQ · Traditional | 09/06/1984SE |
| K842042 | Il 1312, PH Blood Gas Manager · Traditional | 07/11/1984SE |
| K841026 | Manual Blood Cell Counting DeviceGKM · Traditional | 04/04/1984SE |
| K834057 | Il 301 Portable Transcut. Oxygen MoniKLK · Traditional | 02/04/1984SE |
| K833836 | Il Heparinized Flow Directed ThermalDYG · Traditional | 02/04/1984SE |
| K833505 | Il Model 840 Microprocessor LoaderJQW · Traditional | 01/11/1984SE |
| K833841 | Il Test Igg Iga & Igm KitsCZK · Traditional | 01/04/1984SE |
| K830149 | Il Video 22,21 & II Atomic Spectrophoto-DWD · Traditional | 02/28/1983SE |
| K823480 | Il 943 Flame PhotometerJJO · Traditional | 01/09/1983SE |
| K823484 | Thermal Dilution CatheterDYG · Traditional | 12/22/1982SE |
| K823374 | Oxygen Monitor Il 408CCL · Traditional | 12/09/1982SE |
| K822972 | Il 801 Thermaldilution Cardiac OutputDXG · Traditional | 11/01/1982SE |
| K822328 | Il 301 Transcutaneous Oxygen MonitorKLK · Traditional | 09/07/1982SE |
| K821483 | Il 1302 PH Blood Gas AnalyzerCHL · Traditional | 06/10/1982SE |
| K820702 | Il 7F Flow Director Thermal Dilu. CathDYG · Traditional | 04/21/1982SE |
| K820744 | Il Model 1301, PH Blood Gas SystemCHL · Traditional | 04/15/1982SE |
| K820427 | Il 8060 Data Management SystemJQP · Traditional | 03/11/1982SE |
| K812750 | Il 703, Stat SeparatorJRL · Traditional | 01/26/1982SE |
| K812872 | Optional Total Ca-Module for Il 504/508CIS · Traditional | 10/26/1981SE |
| K812762 | Il 501, Na/K AnalyzerJGS · Traditional | 10/20/1981SE |
| K811696 | Il #781, Semi-Automated LoaderJQW · Traditional | 07/01/1981SE |
| K811143 | Ph/Blood Gas Control (Abc)JJS · Traditional | 05/13/1981SE |
| K802398 | Electroly Te Chemistry AnalyzerJJF · Traditional | 10/31/1980SE |
| K802310 | Il Total Protein ReagentCEK · Traditional | 10/23/1980SE |
| K801456 | F/Ls Mca Application SoftwareCFR · Traditional | 10/03/1980SE |
| K801026 | Il Model 773 Fluorescence Light ScatterJJG · Traditional | 05/28/1980SE |
| K801131 | IL88640 & 88641 Cassette-Tape ProgramJQP · Traditional | 05/23/1980SE |
| K801007 | Il System 502 Na/K AnalyzerJGS · Traditional | 05/14/1980SE |
| K800757 | Il Model 1303 Ph/Blood Gas AnalyzerCHL · Traditional | 04/21/1980SE |
| K800282 | Data Management System Il Model 775JQP · Traditional | 03/05/1980SE |
| K791570 | Il Model End Tidal CO2 AnalyzerCCK · Traditional | 09/04/1979SE |
| K782033 | Cardiac Care Q/C Test KitDRL · Traditional | 12/15/1978SE |
| K781081 | Emit Mca Program TapeJQP · Traditional | 09/27/1978SE |
| K781173 | Computer Interface Il 814JQP · Traditional | 09/14/1978SE |
| K781221 | Dilution Kit, Thermal, Cold PacDRC · Traditional | 08/23/1978SE |
| K780522 | Spectrophotometers, Atomic AbsorptionJXR · Traditional | 05/12/1978SE |
| K780521 | Spectrophotometer, Atomic AbsorptionJXR · Traditional | 05/12/1978SE |
| K771977 | Cardiac Output Computer Model 701DSK · Traditional | 01/03/1978SE |
| K771507 | Multistat III Bicarbonate TestKHS · Traditional | 10/25/1977SE |
| K771337 | I.L. Model 643 Flame PhotometerJJO · Traditional | 10/18/1977SE |
| K771604 | Spectrophotometeo Il Model 651JXR · Traditional | 09/22/1977SE |
| K771622 | Multistat III, Amylase TestJFJ · Traditional | 09/13/1977SE |
| K771621 | Multistat III, Total Bilirubin TestCIG · Traditional | 09/13/1977SE |
| K771509 | Multistat III Uric Acid TestCDO · Traditional | 09/13/1977SE |
| K771508 | Multistat III Cholesterol TestCHH · Traditional | 09/13/1977SE |
| K771475 | Multistat III Albumin TestCIX · Traditional | 09/13/1977SE |
| K771474 | Multistat III X-Hbdh TestJMK · Traditional | 09/13/1977SE |
| K771473 | Multistat III Y GT Test · Traditional | 09/13/1977SE |
| K771477 | Multistat III Phosphorous TestCEO · Traditional | 09/12/1977SE |
| K771476 | Multistat III Total Protein TestCEK · Traditional | 09/12/1977SE |
| K771471 | Multistat III Glucose TestCGA · Traditional | 09/12/1977SE |
| K771470 | Multistat III Alkaline PhosphataseCJE · Traditional | 09/12/1977SE |
| K771469 | Multistat III Magnesium TestJGJ · Traditional | 09/12/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2900-2026 Class II | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010…The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not… | 05/21/2026Open, Classified |
| Z-2899-2026 Class II | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008…The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK… | 05/21/2026Open, Classified |
| Z-2826-2026 Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after… | 05/08/2026Open, Classified |
| Z-2825-2026 Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after… | 05/08/2026Open, Classified |
| Z-2824-2026 Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after… | 05/08/2026Open, Classified |
| Z-2823-2026 Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after… | 05/08/2026Open, Classified |
| Z-2822-2026 Class II | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3…BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after… | 05/08/2026Open, Classified |
| Z-2821-2026 Class II | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:…BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after… | 05/08/2026Open, Classified |
| Z-1543-2026 Class II | GEM Premier 5000; Part No. 00055445010 & 00055445011.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1542-2026 Class II | GEM Premier 5000; Part No. 00055445008.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1541-2026 Class II | GEM Premier 5000; Part No. 00055445004.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1540-2026 Class II | GEM Premier 5000; Part No. 00055430011.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1539-2026 Class II | GEM Premier 5000; Model No. 00055430010.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1538-2026 Class II | GEM Premier 5000; Part No. 00055430008.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1537-2026 Class II | GEM Premier 5000; Part No. 00055430004.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1536-2026 Class II | GEM Premier 5000; Part No: 00055415011.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1535-2026 Class II | GEM Premier 5000; Part No. 00055415010.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1534-2026 Class II | GEM Premier 5000; Part No. 00055415008.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1533-2026 Class II | GEM Premier 5000; Part No. 00055415005.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1532-2026 Class II | GEM Premier 5000 PAK; Part No. 00055415004.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1531-2026 Class II | GEM Premier 5000 PAK; Part No. 00055407511.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1530-2026 Class II | GEM Premier 5000 PAK; Part No. 00055407510.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1529-2026 Class II | GEM Premier 5000 PAK; Part No. 00055407508.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1528-2026 Class II | GEM Premier 5000 PAK; Part No. 00055407504.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1527-2026 Class II | GEM Premier 5000 PAK; Part No. 00055360011.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1526-2026 Class II | GEM Premier 5000 PAK; Part No. 00055360010.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1525-2026 Class II | GEM Premier 5000 PAK; Part No. 00055360008.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1524-2026 Class II | GEM Premier 5000 PAK, Part No. 00055360004.Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience… | 01/20/2026Open, Classified |
| Z-1095-2026 Class II | The product is used for the evaluation of the intrinsic coagulation pathway, APTT…Potential for microbial contamination. | 12/11/2025Open, Classified |
| Z-0938-2026 Class III | HemosIL SynthAFax. Partial Thromboplastin Time Tests.Recalled lots were manufactured with double the amount of preservative concentration. | 11/18/2025Open, Classified |
| Z-2323-2025 Class II | HemosIL LMW Heparin Controls; Part Number: 0020300200;Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC… | 02/03/2025Open, Classified |
| Z-1020-2025 Class II | HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnosticControl indicating lower than expected quality control (QC) results and in some instances QC recovery below… | 12/18/2024Open, Classified |
| Z-0359-2024 Class II | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part…Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e.… | 09/29/2023Open, Classified |
| Z-0358-2024 Class II | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507…Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e.… | 09/29/2023Open, Classified |
| Z-0357-2024 Class II | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004…Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e.… | 09/29/2023Open, Classified |
| Z-2578-2023 Class II | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the…Sample misidentification could occur under specific conditions and patient management altered based on an… | 07/13/2023Open, Classified |
| Z-1307-2023 Class II | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |
| Z-1306-2023 Class II | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |
| Z-1305-2023 Class II | ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |
| Z-1304-2023 Class II | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |
| Z-1052-2022 Class II | HemosIL ReadiPlasTin, Part No. 0020301400Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the… | 04/08/2022Open, Classified |
| Z-1014-2022 Class II | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS…Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality… | 02/22/2022Open, Classified |
| Z-0276-2022 Class II | HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic…The firm has received customer reports of performance issues with the affected lot, including increased… | 10/13/2021Open, Classified |
| Z-0151-2022 Class II | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination…Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument… | 08/25/2021Open, Classified |
| Z-0150-2022 Class II | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by…Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument… | 08/25/2021Open, Classified |
| Z-0149-2022 Class II | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination…Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument… | 08/25/2021Open, Classified |
| Z-2487-2019 Class II | ROTEM ex-tem Rest of the world part No: 503-05 (ROW)Prolonged clotting times | 07/23/2019Terminated |
| Z-2486-2019 Class II | ROTEM ex-tem Canada Part No: 503-05-CAProlonged clotting times | 07/23/2019Terminated |
| Z-2485-2019 Class II | ROTEM ex-tem; US Part No: 503-05-USProlonged clotting times | 07/23/2019Terminated |
| Z-0077-2019 Class II | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL…There is a potential for increased imprecision, out of range quality controls and prolonged sample results. | 08/01/2018Terminated |
| Z-0895-2018 Class II | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos.… | 08/02/2017Terminated |
| Z-0736-2016 Class II | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit…This Lot is not meeting labeled on-board instrument stability claims of 5 days. | 12/18/2015Terminated |
| Z-0832-2015 Class II | HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high…Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June… | 11/21/2014Terminated |
| Z-2066-2014 Class II | ACL TOP 300 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2065-2014 Class II | ACL TOP 700 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2064-2014 Class II | ACL TOP 500 CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2063-2014 Class II | ACL TOP 700 LAS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2062-2014 Class II | ACL TOP CTS, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2061-2014 Class II | ACL TOP 700, automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-2060-2014 Class II | ACL TOP (Base), automated coagulation laboratory instrument.Potential for sample misidentification. | 06/03/2014Terminated |
| Z-0516-2014 Class II | HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 11/15/2013Terminated |
| Z-0515-2014 Class II | HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 11/15/2013Terminated |
| Z-0514-2014 Class II | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 11/15/2013Terminated |
| Z-2250-2013 Class II | ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2249-2013 Class II | ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2248-2013 Class II | ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2247-2013 Class II | ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2246-2013 Class II | ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2245-2013 Class II | ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-2244-2013 Class II | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer…Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | 07/19/2013Terminated |
| Z-1784-2013 Class II | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for…Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size)… | 04/09/2013Terminated |
| Z-2392-2012 Class II | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2391-2012 Class II | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2390-2012 Class II | Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2389-2012 Class II | Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2388-2012 Class II | Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-2387-2012 Class II | Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully…Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low | 08/03/2012Terminated |
| Z-1519-2012 | Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part…Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay. | 04/11/2012Terminated |
| Z-2806-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |
| Z-2805-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |
| Z-2804-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |
| Z-2803-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |
| Z-2673-2011 | Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM…Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test… | 05/11/2011Terminated |
| Z-2165-2011 | Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a…Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during… | 02/14/2011Terminated |
| Z-0807-2011 | ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.Sporadically lowered APTT results were observed with the PT/APTT Test Groups. | 11/11/2010Terminated |
| Z-0806-2011 | ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.Sporadically lowered APTT results were observed with the PT/APTT Test Groups. | 11/11/2010Terminated |
| Z-0805-2011 | ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.Sporadically lowered APTT results were observed with the PT/APTT Test Groups. | 11/11/2010Terminated |
| Z-0804-2011 | ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.Sporadically lowered APTT results were observed with the PT/APTT Test Groups. | 11/11/2010Terminated |
| Z-0803-2011 | ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.Sporadically lowered APTT results were observed with the PT/APTT Test Groups. | 11/11/2010Terminated |
| Z-0138-2011 | ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |
| Z-0137-2011 | ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |
| Z-0136-2011 | ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |
| Z-0135-2011 | ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed…Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot… | 08/13/2010Terminated |
| Z-1127-2007 | Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood…ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube. | 06/19/2007Terminated |
| Z-0778-2007 | GEM Premier 4000 Laboratory AnalyzerInstrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect… | 03/27/2007Terminated |