Test, Time, Prothrombin
FDA product code GJS · Class II (moderate risk) · 21 CFR 864.7750 · Hematology
127510(k) clearances
0PMA approvals
60recalls
Manufacturers
- Roche Diagnostics Corp. 14
- Instrumentation Laboratory CO 11
- International Technidyne Corp. 8
- Helena Laboratories 6
- Pacific Hemostasis 5
- Iline Microsystems, S.L. 5
- Organon Teknika Corp. 5
- Cardiovascular Diagnostic Services 4
- Analytical Control Systems, Inc. 4
- American Dade 3
- Coagusense, Inc. 3
- American Bioproducts Co. 3
- Ortho Diagnostic Systems, Inc. 3
- Baxter Healthcare Corp 3
- Hemosense, Inc. 3
- Baxter Diagnostics, Inc. 2
- Avocet Medical, Inc. 2
- Sigma Diagnostics, Inc. 2
- Lifescan, Inc. 2
- Dade Behring, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253188 | CoaguChek XS Plus SystemGJS · Special | Roche Diagnostics | 10/24/2025SE |
| K251564 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 07/21/2025SE |
| K243543 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 02/27/2025SE |
| K230802 | Xprecia Prime Coagulation SystemGJS · Dual Track | Universal Biosensors Pty, Ltd. | 03/15/2024SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | Abbott Laboratories | 07/14/2023SE |
| K231711 | microINR SystemGJS · Special | Iline Microsystems, S.L. | 07/11/2023SE |
| K211485 | STA- NeoPTimalGJS · Traditional | Diagnostica Stago S.A.S | 12/23/2022SE |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special | Coagusense, Inc. | 10/05/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
| K201185 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 12/18/2020SE |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS · Traditional | Coagusense, Inc. | 02/21/2019SE |
| K180780 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 01/25/2019SE |
| K180693 | CoaguChek XS Pro SystemGJS · Special | Roche Diagnostics | 04/19/2018SE |
| K180684 | CoaguChek XS Plus SystemGJS · Special | Roche Diagnostics | 04/19/2018SE |
| K170960 | CoaguChek Vantus SystemGJS · Traditional | Roche Diagnostics | 12/25/2017SE |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT ControlsGJS · Traditional | Siemens Healthcare Diagnostics | 09/30/2016SE |
| K132722 | Hemosil Recombiplastin 2G (8 ML Vial)GJS · Special | Instrumentation Laboratory CO | 01/22/2014SE |
| K122584 | Hemosil Readiplas TinGJS · Traditional | Instrumentation Laboratory CO | 03/24/2013SE |
| K110212 | INRATIO2 Pi/Nr Monitoring System; Inratio Pt/Inr Test StripGJS · Traditional | Alere San Diego, Inc (Formally Biosite Incorporate | 05/01/2012SESU |
| K092987 | INRATIO/INRATIO2 Test StripsGJS · Traditional | Biosite Incorporated | 06/11/2010SE |
| K093243 | Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemGJS · Traditional | Coagusense, Inc. | 04/07/2010SE |
| K093460 | Coaguchek XS Pro SystemGJS · Traditional | Roche Diagnostics | 03/18/2010SE |
| K092940 | Coaguchek XS Plus PST SystemGJS · Traditional | Roche Diagnostics Corp. | 03/05/2010SE |
| K072920 | Handheld Base UnitGJS · Abbreviated | Roche Diagnostics Corp. | 01/31/2008SE |
| K072727 | Inratio 2 PT Monitoring SystemGJS · Special | Hemosense, Inc. | 10/26/2007SE |
| K070005 | Hemosil Recombiplastin 2GGJS · Traditional | Instrumentation Laboratory CO | 08/15/2007SE |
| K071041 | Coaguchek XS Plus SystemGJS · Special | Roche Diagnostics | 05/11/2007SE |
| K062925 | Coaguchek XS SystemGJS · Traditional | Roche Diagnostics Corp. | 01/29/2007SE |
| K060978 | Coaguchek XS SystemGJS · Traditional | Roche Diagnostics | 08/11/2006SE |
| K060931 | Hemosil Pt-Fibrinogen HS PlusGJS · Special | Instrumentation Laboratory CO | 05/02/2006SE |
| K052124 | Acticlot, Model 824GJS · Traditional | American Diagnostica, Inc. | 10/17/2005SE |
| K043184 | Hemosil RecombiplastinGJS · Special | Instrumentation Laboratory CO | 12/22/2004SE |
| K040296 | Phosphoplastin RLGJS · Traditional | R2 Diagnostics, Inc. | 05/24/2004SE |
| K030845 | Coaguchek Pt.S Test for Prothrombin Time Self-TestingGJS · Traditional | Roche Diagnostics Corp. | 05/22/2003SE |
| K021190 | Pt-S Test Strips for the Coaguchek System, Model# 2032422GJS · Traditional | Roche Diagnostics Corp. | 10/25/2002SE |
| K021923 | Inratio Self-TestGJS · Traditional | Hemosense, Inc. | 10/24/2002SE |
| K020831 | PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404GJS · Traditional | Roche Diagnostics Corp. | 10/24/2002SE |
| K022922 | Harmony Inr Monitoring SystemGJS · Special | Lifescan, Inc. | 09/30/2002SE |
| K020840 | Vital Scientific PT with CalciumGJS · Traditional | Vital Scientific N.V. | 05/15/2002SE |
| K020355 | I-Stat Prothrombin Time TestGJS · Traditional | I-Stat Corporation | 05/14/2002SE |
| K020679 | InratioGJS · Traditional | Hemosense, Inc. | 05/06/2002SE |
| K013155 | Dade Thromboplastin C PlusGJS · Traditional | Dade Behring, Inc. | 01/18/2002SE |
| K012768 | Hemosil Recombi PlastinGJS · Traditional | Instrumentation Laboratory CO | 09/18/2001SE |
| K010599 | Protime Microcoagulation System / Protime 3 CuvetteGJS · Special | International Technidyne Corp. | 07/02/2001SE |
| K001699 | Rubicon Prothrombin Time Monitoring SystemGJS · Traditional | Lifescan, Inc. | 05/15/2001SE |
| K003870 | Thromborel SGJS · Traditional | Dade Behring, Inc. | 02/20/2001SE |
| K994100 | Pacific Hemostasis Thromboplastin DGJS · Traditional | Pacific Hemostasis | 02/18/2000SE |
| K994006 | Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use)GJS · Traditional | Avocet Medical, Inc. | 02/03/2000SE |
| K991286 | Avocet Acusure SystemGJS · Traditional | Avocet Medical, Inc. | 11/18/1999SE |
| K992492 | PTN Test Cartridges for Coaguchek Pro System, PTN Controls for Coaguchek Pro SystemGJS · Traditional | Roche Diagnostics Corp. | 11/02/1999SE |
| K991065 | Careside PTGJS · Traditional | Careside, Inc. | 07/26/1999SE |
| K972866 | Hemochron Jr. Miocrocoagulation Citrated PTGJS · Traditional | International Technidyne Corp. | 09/30/1998SE |
| K974343 | Dade InnovinGJS · Traditional | Dade Intl., Inc. | 07/22/1998SE |
| K981479 | Il Test Pt-Fibrinogen RecombinantGJS · Traditional | Instrumentation Laboratory CO | 07/07/1998SE |
| K974566 | Mda Simplastin HTFGJS · Traditional | Organon Teknika Corp. | 02/24/1998SE |
| K972796 | Sigma Diagnostics Thrombomax with CalciumGJS · Traditional | Sigma Diagnostics, Inc. | 10/10/1997SE |
| K962571 | Coaguchek PST SystemGJS · Traditional | Boehringer Mannheim Corp. | 04/22/1997SE |
| K961835 | Protime Microcoagulation SystemGJS · Traditional | International Technidyne Corp. | 03/12/1997SE |
| K961938 | Stat Profile Ultra L Analyzer Quality Control MaterialsGJS · Traditional | Nova Biomedical Corp. | 06/28/1996SE |
| K955843 | Tas PtoneGJS · Traditional | Cardiovascular Diagnostic Services | 03/18/1996SE |
| K954625 | Prothrombin Time Test CardGJS · Traditional | Cardiovascular Diagnostics, Inc. | 03/11/1996SE |
| K951820 | Thromboplastin-Li ReagentGJS · Traditional | Helena Laboratories | 10/20/1995SE |
| K952608 | Mda Simplastin LSGJS · Traditional | Organon Teknika Corp. | 10/06/1995SE |
| K942884 | Coaguchek SystemGJS · Traditional | Boehringer Mannheim Corp. | 05/11/1995SE |
| K945078 | Hemochron Hnpt/Factor Vi Pt+GJS · Traditional | International Technidyne Corp. | 04/28/1995SE |
| K935748 | Ortho Recombiplastin II W/Ortho Recombiplastin II DiluentGJS · Traditional | Ortho Diagnostic Systems, Inc. | 04/26/1995SE |
| K940082 | Thromboscreen Thromboplastin-DsGJS · Traditional | Pacific Hemostasis | 02/14/1995SE |
| K935702 | Dade Innovin IIGJS · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K940432 | Microcoagulation Prothrombin Time TestGJS · Traditional | International Technidyne Corp. | 05/18/1994SE |
| K940310 | Helena Thromboplastin-Mi ReagentGJS · Traditional | Helena Laboratories | 04/20/1994SE |
| K931118 | Assess(Tm) High Abnormal ControlGJS · Traditional | Instrumentation Laboratory CO | 03/30/1994SE |
| K931117 | Assess(Tm) Low Abnormal ControlGJS · Traditional | Instrumentation Laboratory CO | 03/30/1994SE |
| K933252 | Il Test (TM) Pt-Fibrinogen HS PlusGJS · Traditional | Instrumentation Laboratory CO | 10/04/1993SE |
| K930212 | Thromboplatin-M with CalciumGJS · Traditional | Sigma Diagnostics, Inc. | 05/11/1993SE |
| K925604 | Ortho(Tm) Recombiplastin W/Ortho DiluentGJS · Traditional | Ortho Diagnostic Systems, Inc. | 03/12/1993SE |
| K920767 | NycoplastinGJS · Traditional | Nycomed Pharma AS | 02/12/1993SE |
| K925492 | Biomerieux Hemolab ThrombomatGJS · Traditional | Biomerieux Vitek, Inc. | 02/03/1993SE |
| K922565 | Neoplastine(R) Ci KitGJS · Traditional | American Bioproducts Co. | 12/07/1992SE |
| K921326 | Dade Recomboplastin SGJS · Traditional | Baxter Diagnostics, Inc. | 07/27/1992SE |
| K922040 | Neoplastine Ci PlusGJS · Traditional | American Bioproducts Co. | 06/23/1992SE |
| K915746 | Simplastin LGJS · Traditional | Organon Teknika Corp. | 02/12/1992SE |
| K913249 | Acs ULTRA-1 ThromboplastinGJS · Traditional | Analytical Control Systems, Inc. | 12/04/1991SE |
| K913250 | Acs ULTRA-2 ThromboplastinGJS · Traditional | Analytical Control Systems, Inc. | 11/27/1991SE |
| K912102 | Acs Liquid ThromboplastinGJS · Traditional | Analytical Control Systems, Inc. | 08/09/1991SE |
| K911995 | Prothrombin Time (PT) by Hemochron, ModificationGJS · Traditional | International Technidyne Corp. | 07/17/1991SE |
| K905807 | Helena Thromboplastin Reagent with DiluentGJS · Traditional | Helena Laboratories | 04/16/1991SE |
| K905857 | Helena Thromboplastin Reagent, ModificationGJS · Traditional | Helena Laboratories | 02/27/1991SE |
| K904325 | COAG-1 Pt-Nc Test CardGJS · Traditional | Cardiovascular Diagnostic Services | 01/25/1991SE |
| K904454 | Hemochron(R) Prothrombin Time/ModificationGJS · Traditional | International Technidyne Corp. | 12/17/1990SE |
| K902468 | Acs One-Stage Prothrombin Time ReagentGJS · Traditional | Analytical Control Systems, Inc. | 08/10/1990SE |
| K903019 | Modified COAG-1 PT Test CardGJS · Traditional | Cardiovascular Diagnostic Services | 08/01/1990SE |
| K902096 | Thromboplastin with CalciumGJS · Traditional | Sigma Chemical Co. | 07/03/1990SE |
| K901325 | Thromboplastin.C PlusGJS · Traditional | Baxter Healthcare Corp | 05/02/1990SE |
| K896625 | Thromboplastin, for Use in Prothrombin Time Deter.GJS · Traditional | Medical Diagnostic Technologies, Inc. | 12/11/1989SE |
| K885107 | Thrombostin Ifa*GJS · Traditional | Investigacion Farmaceutica S.A. DE C.V. | 06/23/1989SE |
| K893378 | Prothrombin Time (PT) by HemochronGJS · Traditional | International Technidyne Corp. | 06/22/1989SE |
| K892050 | Helena Thromboplastin ReagentGJS · Traditional | Helena Laboratories | 06/07/1989SE |
| K891370 | Edl One-Stage Prothrombin Time ReagentGJS · Traditional | Elite Diagnostic , Ltd. | 04/21/1989SE |
| K891169 | Dade Thromboplastin IsGJS · Traditional | Baxter Healthcare Corp | 04/10/1989SE |
| K884855 | ThromboplastinGJS · Traditional | Precision Biologicals, Inc. | 01/30/1989SE |
| K883441 | Vision(R) Prothrombin TimeGJS · Traditional | Abbott Laboratories | 09/13/1988SE |
| K882456 | Coag-I PT Test CardGJS · Traditional | Cardiovascular Diagnostic Services | 08/25/1988SE |
| K882214 | Simplastin Excel SGJS · Traditional | Organon Teknika Corp. | 07/01/1988SE |
| K880566 | CLP Prothrombin Time TestGJS · Traditional | Creative Laboratory Products, Inc. | 03/23/1988SE |
| K875062 | Easy-Test Prothrombin Time PT Item No. 16628GJS · Traditional | Em Diagnostic Systems, Inc. | 02/11/1988SE |
| K874592 | Thromboplastin.CGJS · Traditional | Baxter Healthcare Corp | 02/04/1988SE |
| K872537 | Prothrombin Time TestGJS · Traditional | Sclavo, Inc. | 08/27/1987SE |
| K872844 | Thromborel SGJS · Traditional | Behring Diagnostics, Inc. | 08/06/1987SE |
| K870596 | Prothrombin Time TestGJS · Traditional | U. S. Diagnostics, Inc. | 04/20/1987SE |
| K864392 | Protime Automate Test KitGJS · Traditional | American Bioproducts Co. | 01/05/1987SE |
| K864283 | Simplastin ExcelGJS · Traditional | Organon Teknika Corp. | 12/04/1986SE |
| K864274 | Thromboplastin.RGJS · Traditional | American Dade | 11/13/1986SE |
| K864273 | Thromboplastin.CGJS · Traditional | American Dade | 11/13/1986SE |
| K864272 | Thromboplastin.FsGJS · Traditional | American Dade | 11/13/1986SE |
| K860721 | Biotrack Protime Test Prothrombin Time TestGJS · Traditional | Biotrack, Inc. | 05/23/1986SE |
| K852484 | PlastinexGJS · Traditional | Bio/Data Corp. | 08/12/1985SE |
| K851125 | Aca Prothrombin Time Analytical Test PackGJS · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/29/1985SE |
| K843535 | Ortho Brain Thromboplastin DiluentGJS · Traditional | Ortho Diagnostic Systems, Inc. | 12/12/1984SE |
| K840802 | Dia Thrombin Dia PlastinGJS · Traditional | Diatech, Inc. | 05/01/1984SE |
| K832427 | Easytouch Tromboplastin ReagentGJS · Traditional | Worthington Diagnostic Systems | 10/14/1983SE |
| K830331 | Liquid Thromboplastin ReagentGJS · Traditional | Helena Laboratories | 04/05/1983SE |
| K811784 | Sigma Procedure #890GJS · Traditional | Sigma Chemical Co. | 07/27/1981SE |
| K810350 | ThromboplastinGJS · Traditional | Pacific Hemostasis | 04/14/1981SE |
| K792031 | Lancer Coagent PT KitGJS · Traditional | Sherwood Medical Co. | 11/05/1979SE |
| K791022 | Prothrombin Reference Plasma (Human)GJS · Traditional | Pacific Hemostasis | 07/24/1979SE |
| K791023 | Prothrombin Free Beef Plasma (PFB)GJS · Traditional | Pacific Hemostasis | 06/28/1979SE |
| K780203 | Thromboplastin DriedGJS · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 03/27/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1503-2025 Class II | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin…The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | Fisher Diagnostics | 03/06/2025Open, Classified |
| Z-1502-2025 Class II | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time…The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | Fisher Diagnostics | 03/06/2025Open, Classified |
| Z-1583-2022 Class II | a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, 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… | Instrumentation Laboratory | 04/08/2022Open, 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… | Instrumentation Laboratory | 10/13/2021Open, Classified |
| Z-0804-2021 Class II | CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for…Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing… | Roche Diagnostics Operations, Inc. | 12/02/2020Terminated |
| Z-0803-2021 Class II | CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for…Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing… | Roche Diagnostics Operations, Inc. | 12/02/2020Terminated |
| Z-0787-2019 Class I | CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT…Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who… | Terrific Care LLC | 12/20/2018Terminated |
| Z-0360-2019 Class I | CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog…Abnormally high INR test results with the affected CoaguChek test strips | Roche Diagnostics Corporation | 09/13/2018Terminated |
| 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. | Instrumentation Laboratory Co. | 08/01/2018Terminated |
| Z-2994-2018 Class II | Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination…QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) | Diagnostica Stago, Inc. | 07/24/2018Terminated |
| Z-2993-2018 Class II | Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for…QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) | Diagnostica Stago, Inc. | 07/24/2018Terminated |
| Z-1069-2018 Class II | STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Diagnostica Stago, Inc. | 10/25/2017Terminated |
| Z-1068-2018 Class II | STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Diagnostica Stago, Inc. | 10/25/2017Terminated |
| Z-1067-2018 Class II | Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Diagnostica Stago, Inc. | 10/25/2017Terminated |
| Z-1066-2018 Class II | Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | Diagnostica Stago, Inc. | 10/25/2017Terminated |
| 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.… | Instrumentation Laboratory Co. | 08/02/2017Terminated |
| Z-2362-2016 Class I | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Test Strips. This… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2361-2016 Class I | Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2360-2016 Class I | Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage:…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2359-2016 Class I | Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2358-2016 Class I | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2357-2016 Class I | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage:…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2356-2016 Class I | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2355-2016 Class I | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2354-2016 Class I | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere…Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System… | Alere San Diego, Inc. | 07/11/2016Terminated |
| Z-2361-2015 Class II | i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed…Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially… | Abbott Point Of Care Inc. | 06/15/2015Terminated |
| Z-0882-2015 Class I | INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System -…In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower… | Alere San Diego, Inc. | 12/05/2014Terminated |
| Z-0881-2015 Class I | INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio…In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower… | Alere San Diego, Inc. | 12/05/2014Terminated |
| Z-0880-2015 Class I | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071…In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower… | Alere San Diego, Inc. | 12/05/2014Terminated |
| 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… | Instrumentation Laboratory Co. | 11/21/2014Terminated |
| Z-1546-2014 Class I | Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere…Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or… | Alere San Diego, Inc. | 04/16/2014Terminated |
| Z-0451-2014 Class II | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The…Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit… | Abbott Point Of Care Inc. | 10/28/2013Terminated |
| Z-2198-2013 Class II | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the…The products may have been stored at temperatures outside their required storage conditions. | Assuramed | 07/16/2013Terminated |
| Z-1584-2013 Class II | CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | Roche Diagnostics Operations, Inc. | 05/16/2013Terminated |
| Z-1583-2013 Class II | CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | Roche Diagnostics Operations, Inc. | 05/16/2013Terminated |
| Z-1582-2013 Class II | CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | Roche Diagnostics Operations, Inc. | 05/16/2013Terminated |
| Z-1581-2013 Class II | CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS…Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS… | Roche Diagnostics Operations, Inc. | 05/16/2013Terminated |
| 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)… | Instrumentation Laboratory Co. | 04/09/2013Terminated |
| Z-1114-2013 Class II | CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the…Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading… | Roche Diagnostics Operations, Inc. | 03/06/2013Terminated |
| Z-0837-2013 Class II | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50.…Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin… | International Technidyne Corp. | 09/28/2012Terminated |
| Z-2157-2012 Class II | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This…The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. | Abbott Point Of Care Inc. | 03/01/2012Terminated |
| Z-2661-2011 | 0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the…The recall of the Triad Group alcohol prep products is due to potential contamination of these products with… | Alere San Diego | 02/28/2011Terminated |
| Z-1519-2011 | Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed…An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality… | Fisher Diagnostics, A Company of Fisher… | 10/06/2010Terminated |
| Z-1996-2010 | i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJA high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to… | Abbott Point of Care Inc. | 05/05/2010Terminated |
| Z-2004-2009 | Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | Roche Diagnostics Operations, inc. | 07/22/2009Terminated |
| Z-2003-2009 | Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | Roche Diagnostics Operations, inc. | 07/22/2009Terminated |
| Z-2002-2009 | Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | Roche Diagnostics Operations, inc. | 07/22/2009Terminated |
| Z-1594-2009 | Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis…The lancet cap may be missing, which could result in an unintended lancet stick to the user. | Roche Diagnostics Corp. | 05/13/2009Terminated |
| Z-1256-2009 | HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The…INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors… | HemoSense Inc | 12/23/2008Terminated |