Helena Laboratories
Medical device manufacturer in Beaumont, TX.
282510(k) clearances
0PMA approvals
16recalls
Device types
- LCP Assay, Glycosylated Hemoglobin 19
- GGP Test, Qualitative And Quantitative Factor… 17
- CEF Electrophoretic, Protein Fractionation 15
- JHO Electrophoretic Separation, Lipoproteins 15
- KHE Reagent, Occult Blood 12
- JBD System, Analysis, Electrophoretic Hemoglobin 11
- CFE Electrophoretic, Lactate Dehydrogenase… 11
- JJY Multi-Analyte Controls, All Kinds (Assayed) 11
- JPA System, Multipurpose For In Vitro… 8
- JJN Apparatus, Electrophoresis, For Clinical Use 8
- GGN Plasma, Coagulation Control 7
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 7
- GJS Test, Time, Prothrombin 6
- CFF Immunoelectrophoretic, Immunoglobulins, (G… 6
- GHR Reagent, Platelet Aggregation 6
- JPD Hemoglobin A2 Quantitation 6
- GKP Instrument, Coagulation, Automated 5
- JJX Single (Specified) Analyte Controls… 5
- CIN Electrophoretic Separation, Alkaline… 5
- JOZ System, Automated Platelet Aggregation 4
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213396 | SPIFE A1AT kitOBZ · Traditional | 10/13/2022SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | 04/19/2022SE |
| K131479 | V8 SP Normal Control, Abnormal ControlJJY · Traditional | 10/07/2013SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | 02/23/2007SE |
| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | 02/14/2003SE |
| K022757 | Spife CK Kit, Model 3332, 3333JHY · Traditional | 10/11/2002SE |
| K022455 | Spife LD-12 Kit, Model 3338CFE · Traditional | 10/01/2002SE |
| K022333 | Spife LIPPOROTEIN-12, Model 3344JHO · Traditional | 08/15/2002SE |
| K020914 | Actalyke XL Activated Clotting Time Analyzer, Model 5770JBP · Traditional | 05/23/2002SE |
| K020625 | Spife 2000/3000 Alp 40, 20; Models 3345 and 3346CIN · Traditional | 05/06/2002SE |
| K020467 | Spife LD Vis Isoenzyme Kit, Models 3450, 3451, and 3452CFE · Traditional | 03/29/2002SE |
| K013078 | Actalyke Mini Activated Clotting Time Test System, Model 5750/5752JBP · Traditional | 01/10/2002SE |
| K013466 | Spife 2000/3000 Lipoprotein; Model# 3340, 3341, 3342, 3343JHO · Traditional | 12/21/2001SE |
| K012723 | PlateletworksJOZ · Traditional | 09/28/2001SE |
| K010617 | Spife Ife Calibrator and Control KitDEW · Traditional | 03/15/2001SE |
| K003359 | Coloscreen-EsKHE · Traditional | 11/27/2000SE |
| K000603 | Spife Cholesterol Profile KitJHO · Traditional | 04/17/2000SE |
| K992971 | Rep Cholesterol Profile KitJHO · Traditional | 10/18/1999SE |
| K992199 | Acid Hemoglobin KitJBD · Traditional | 09/21/1999SE |
| K990998 | Polyslit Ife KitCFF · Traditional | 06/28/1999SE |
| K982426 | Spife Alkaline HemoglobinJBD · Traditional | 12/17/1998SE |
| K982639 | Spife Urine IfeDAO · Traditional | 11/04/1998SE |
| K980671 | Coloscreen-EsKHE · Traditional | 05/12/1998SE |
| K980650 | Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis CholesterolJHO · Traditional | 05/01/1998SE |
| K974609 | Rep Cholesterol Profile Control-IiJJX · Traditional | 01/06/1998SE |
| K973040 | Spife IFE-6CFF · Traditional | 01/02/1998SE |
| K972274 | SpifeCEF · Traditional | 10/27/1997SE |
| K973316 | Rep Spe VIS-60/40 KitCEF · Traditional | 10/01/1997SE |
| K962914 | Rep 3 Quto-Flur CHOLESTEROL-30JHO · Traditional | 01/13/1997SE |
| K964471 | Rep Flur CHOLESTEROL-60 KitJHO · Traditional | 12/23/1996SE |
| K964453 | Rep 3 Flur SPE-60 KitCEF · Traditional | 12/23/1996SE |
| K961908 | Thor Henostatsis Analyzer Cat. No. 1450, 1451JPA · Traditional | 12/10/1996SE |
| K960571 | Rapid Electrophoresis AnalyzerJHO · Traditional | 10/25/1996SE |
| K952321 | Porcine Factor Viii;C ReagentGGN · Traditional | 03/11/1996SE |
| K952667 | Chrom Z-Heparin, Cat. No 5242KFF · Traditional | 02/14/1996SE |
| K952668 | Chrom Z-F:Viii, Cat. No. 5241GGP · Traditional | 02/09/1996SE |
| K952666 | Chrom Z-Protein C, Cat. No. 5243GGP · Traditional | 01/30/1996SE |
| K952669 | Chrom Z-Plasminogen, Cat. No. 5244GGP · Traditional | 12/07/1995SE |
| K951943 | Chrom Z Chromogenic AssaysJBQ · Traditional | 11/13/1995SE |
| K951820 | Thromboplastin-Li ReagentGJS · Traditional | 10/20/1995SE |
| K952252 | Adp Reagent, ModifiedGHR · Traditional | 09/08/1995SE |
| K951497 | Cascase 480 SnslyzerJPA · Traditional | 09/01/1995SE |
| K946274 | Columnmate II GHB Affinity Regenerable ColumnLCP · Traditional | 07/11/1995SE |
| K950801 | Cardio Rep LD Control - Cat No. 3325JJT · Traditional | 03/30/1995SE |
| K950590 | Rep Cholesterol Profile ControlJJX · Traditional | 03/30/1995SE |
| K935169 | Aptt-EsGFO · Traditional | 12/02/1994SE |
| K941872 | Specialty Assayed CONTROL-2 Cat. No. 5302GGC · Traditional | 11/21/1994SE |
| K935162 | Rep Direct-Sep CHOLESTEROL-15 Kit; CHOLESTEROL-8 Kit; CHOLESTEROL-4 KitJHO · Traditional | 11/10/1994SE |
| K933086 | Afsc Hemo Control #5331, AA2 Hemo Control #5328JCM · Traditional | 10/31/1994SE |
| K941737 | Specialty Assayed CONTROL-1GIZ · Traditional | 10/07/1994SE |
| K941860 | Specialty Assayed Reference Plasma (S.A.R.P.)GGN · Traditional | 09/14/1994SE |
| K940679 | Rep HDL/LDL-30 Kit - Cat. No. 3220,3221,3222JHO · Traditional | 09/09/1994SE |
| K940224 | Cardio Rep LDCFE · Traditional | 08/17/1994SE |
| K940310 | Helena Thromboplastin-Mi ReagentGJS · Traditional | 04/20/1994SE |
| K933277 | Coagulation A.R.P.GGN · Traditional | 03/22/1994SE |
| K932442 | Cardio Rep Recombinant CK Abnormal ControlJJT · Traditional | 10/28/1993SE |
| K932768 | Cardio Rep CK Calibrators 1 & 2 Cat. No. 3322 & 3323JIX · Traditional | 10/18/1993SE |
| K931956 | Cascade M, Cat. No. 1710GKP · Traditional | 08/23/1993SE |
| K931503 | Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional | 08/16/1993SE |
| K930317 | Rep Spe Hi-Res Template System, Cat 3276/3277/3278CEF · Traditional | 08/03/1993SE |
| K931465 | Rep Alkaline HB-15 #3196,-8 #3197,-4 3198JBD · Traditional | 07/06/1993SE |
| K931247 | Titan Gel IMMUNOFIX-9 Cat. No. 3051 and 3067DAH · Traditional | 04/27/1993SE |
| K931050 | Cardio Rep CK Isoenzyme Kit - 3310JHW · Traditional | 04/20/1993SE |
| K930359 | Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional | 04/12/1993SE |
| K926222 | Owren's Veronal Buffer #5375 & Fibronogen KIT#5376JPA · Traditional | 02/12/1993SE |
| K925801 | Rep E-Z CK-30 Isoenzyme KitCGS · Traditional | 12/28/1992SE |
| K924915 | Scale Set SOLUTIONS/405NM CAT#1480-650NM CAT#1479JJY · Traditional | 12/18/1992SE |
| K923658 | Rep ImmunofixCFF · Traditional | 11/02/1992SE |
| K921578 | Titan Gel Alkaline Phosphatase (HR)CIN · Traditional | 09/23/1992SE |
| K923318 | Columnmate Beta-Thal HBA2 Control - NormalJPD · Traditional | 08/25/1992SE |
| K923317 | Columnmate Beta Thal HBA2 Control-AbnormalJPD · Traditional | 08/25/1992SE |
| K922053 | Rep Spe Plus (Ponceau S) SystemCEF · Traditional | 08/18/1992SE |
| K920820 | Modification ColumnmateLCP · Traditional | 08/17/1992SE |
| K922024 | Rep Spe Plus (Acid Blue) System,# 3173/3174/3175CEF · Traditional | 07/23/1992SE |
| K921676 | Columnmate IILCP · Traditional | 07/10/1992SE |
| K921465 | Cat. No. 1471 (110V) & Cat. No. 1472 (220V)GKP · Traditional | 06/29/1992SE |
| K920927 | Kemtrol Serum Control-Normal Cat No. 7024JJY · Traditional | 06/19/1992SE |
| K921363 | Cascade 480GKP · Traditional | 06/09/1992SE |
| K921305 | Glyco-Tek Affinity Column KitLCP · Traditional | 06/09/1992SE |
| K920926 | Kemtrol Serum Control-AbnormalJJY · Traditional | 05/07/1992SE |
| K920147 | Thrombin Clotting Time ReagentGJA · Traditional | 05/01/1992SE |
| K914949 | Coagulation ARPR,CAT.NO.5185GGN · Traditional | 03/04/1992SE |
| K915418 | Ellagic Acid Aptt ReagentGFO · Traditional | 02/14/1992SE |
| K914946 | Cascade 480(TM) Auto Coag Analyzer, ModificationGKP · Traditional | 01/13/1992SE |
| K913384 | Columnmate(Tm) Beta-Thal Cat. No. 4515JPD · Traditional | 12/17/1991SE |
| K913807 | Rep(R) Spe Template 30, 16, & 8CEF · Traditional | 11/27/1991SE |
| K913058 | Rep(Tm) Spe TEMP-30-16-8 Procedure, 3170,3171,3172CEF · Traditional | 10/30/1991SE |
| K912774 | Arachidonic AcidJBX · Traditional | 08/22/1991SE |
| K911777 | Rocket Reference Plasma, Cat. No. 5188, ModifiedGGN · Traditional | 08/22/1991SE |
| K912201 | PACKS-4 (TM) AnalyzerJBY · Traditional | 08/16/1991SE |
| K912603 | Rep ALP-15, 8, & 4 KitsCIN · Traditional | 07/30/1991SE |
| K912386 | Rep Spe Plus (Ponceau S) System, 3163, 3164 & 3165CEF · Traditional | 07/17/1991SE |
| K911075 | ColoscreenKHE · Traditional | 07/03/1991SE |
| K905798 | ColocareKHE · Traditional | 07/03/1991SE |
| K910800 | Adp ReagentGHR · Traditional | 05/20/1991SE |
| K910706 | Collagen Reagent Cat. No. 5368GHR · Traditional | 05/20/1991SE |
| K910680 | Epinephrine Reagent, Cat. No. 5367GHR · Traditional | 05/20/1991SE |
| K911468 | Rep Spe Plus (Acid Blue) SystemCEF · Traditional | 04/16/1991SE |
| K905807 | Helena Thromboplastin Reagent with DiluentGJS · Traditional | 04/16/1991SE |
| K905857 | Helena Thromboplastin Reagent, ModificationGJS · Traditional | 02/27/1991SE |
| K905673 | Ab-Trol II Coagulation Control Plasm Cat. No. 5183GGN · Traditional | 02/11/1991SE |
| K904247 | Free Protein S Reagent Cat. No. 5363GGP · Traditional | 01/18/1991SE |
| K905149 | Titan GelDAH · Traditional | 01/03/1991SE |
| K904035 | Rep Ultra Hdl,Vldl/Ldl Cholesterol SystemLBT · Traditional | 11/09/1990SE |
| K902083 | Chrom-Trol Cat. No. 5300 W/ New AnalyteGJT · Traditional | 06/15/1990SE |
| K901414 | Columnmate (Automated Column System) 1580, 1581LCP · Traditional | 06/15/1990SE |
| K901463 | Rep(Tm) Spe PLUS-16 (Ponceau S) and (Amido)JQJ · Traditional | 06/12/1990SE |
| K901805 | Rep(R) ImmunofixDAH · Traditional | 06/06/1990SE |
| K901380 | Cascade 480(TM) Automated Coagulation Analy. 1430GKP · Traditional | 05/25/1990SE |
| K901143 | Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional | 05/23/1990SE |
| K896670 | Tip Top(R) Dispenser CapsGJW · Traditional | 03/23/1990SE |
| K896174 | Protein S Antigen Rocket Eid Kit, Cat. No. 5359GGP · Traditional | 03/15/1990SE |
| K900422 | Titan Gel Immunofix Kit, Cat. No. 3046CZP · Traditional | 02/27/1990SE |
| K900251 | Rep Spe PLUS-8 (Ponceau S) 3165, PLUS-8 No. 3175CEF · Traditional | 02/26/1990SE |
| K896170 | Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional | 02/16/1990SE |
| K897136 | Protein C Antigen Rocket Eid Method No. 5357GGP · Traditional | 02/05/1990SE |
| K900017 | Rep Glyco Control NORMAL(3209) and ABNORMAL(3210)JPK · Traditional | 01/29/1990SE |
| K900019 | Rocket Reference Plasma, Cat No. 5188GGN · Traditional | 01/25/1990SE |
| K896572 | Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional | 01/11/1990SE |
| K893038 | Protofluor ZJKJ · Traditional | 11/17/1989SE |
| K895528 | Gel Alkaline Phosphatase Isoenzyme Control NO.5104JJX · Traditional | 10/25/1989SE |
| K894585 | Rep TM Spe (Ponceau S) ProceduresCEF · Traditional | 09/13/1989SE |
| K894366 | Rep HDL-8 Kit, No. 3188, Rep HDL-16 Kit, No. 3187LBT · Traditional | 08/31/1989SE |
| K893007 | Rep(Tm) CK-2 Stat Kit, Cat. No. 3074CGS · Traditional | 07/20/1989SE |
| K893224 | Rep GLYCO-8 Kit, #3208/REP GLYCO-16 Kit, #3207LCP · Traditional | 06/20/1989SE |
| K892818 | Rep(Tm) LD-2 Stat Kit, Cat. No. 3078CFE · Traditional | 06/20/1989SE |
| K893211 | Rep SPE-8 Kit, Cat.# 3172/REP SPE-16 Kit CAT.#3171CEF · Traditional | 06/19/1989SE |
| K893223 | Rep LIPO-8 Kit, No. 3182/REP LIPO-16 Kit, No. 3181JHO · Traditional | 06/09/1989SE |
| K892424 | Rep Spe Hi-Res System No. 3176, 3177, 3178CFF · Traditional | 06/09/1989SE |
| K892050 | Helena Thromboplastin ReagentGJS · Traditional | 06/07/1989SE |
| K891683 | Titan Gel Ife Free Kappa/Lamba Light Chain AntiserCZN · Traditional | 04/12/1989SE |
| K891299 | Mid-Level Igg Kit Cat. No. 9315DAQ · Traditional | 03/22/1989SE |
| K891188 | Titan Gel Ife Trivalent AntiserumCFQ · Traditional | 03/22/1989SE |
| K885341 | Titan Gel Alkaline Phosphatase (HR)CIN · Traditional | 02/23/1989SE |
| K884315 | Labile Lysing ReagentLCP · Traditional | 12/27/1988SE |
| K884111 | Pumpette(Tm)JKA · Traditional | 12/14/1988SE |
| K882799 | Helena ColocareKHE · Traditional | 09/30/1988SE |
| K881863 | Rep Glyco SystemLCP · Traditional | 09/30/1988SE |
| K883484 | Owren's Veronal BufferJPA · Traditional | 08/25/1988SE |
| K882368 | Rep HDL Electrophoresis MethodLBT · Traditional | 08/08/1988SE |
| K881852 | Rep SP Electrophoresis System Cat No. 3170JJN · Traditional | 07/08/1988SE |
| K882163 | Helena Rep Gel ProcessorJJN · Traditional | 06/20/1988SE |
| K881809 | Rep Lipo Kit Cat. No 3180JHO · Traditional | 06/01/1988SE |
| K880698 | Titan Gel-Pc Glyco-Heme(Tm) SystemLCP · Traditional | 05/06/1988SE |
| K880653 | HBF DiluentKQI · Traditional | 04/21/1988SE |
| K880292 | Factor Viii Reference PlasmaGJT · Traditional | 02/19/1988SE |
| K874145 | Titan Gel Rep LDH-6 HVCFE · Traditional | 11/24/1987SE |
| K874142 | Titan Gel Rep LDH-30 HVCFE · Traditional | 11/24/1987SE |
| K874144 | Titan Gel Rep CPK-6 HVJHX · Traditional | 11/23/1987SE |
| K874143 | Titan Gel Rep LDH-12 HVCFE · Traditional | 11/23/1987SE |
| K873384 | Chromogenic System Analyzer Spectrophotometer CsaJJQ · Traditional | 11/20/1987SE |
| K874146 | Titan Gel Rep CPK-12 HVCGS · Traditional | 11/05/1987SE |
| K874141 | Titan Gel Rep Cpk/Ldh Isoenzyme ControlJJT · Traditional | 11/04/1987SE |
| K874140 | Titan Gel Rep Simultaneous Ck-Ld Isoenzyme Proced.CGS · Traditional | 11/03/1987SE |
| K874139 | Titan Gel Rep CPK-30 HVCGS · Traditional | 11/03/1987SE |
| K873399 | Titan Gel CPK Rep SystemJHX · Traditional | 10/20/1987SE |
| K873386 | Titan Gel LDH Rep SystemCFE · Traditional | 10/20/1987SE |
| K873547 | Titan Gel HDL Cholesterol KitLBT · Traditional | 10/02/1987SE |
| K873352 | Rapid Electrophoresis System (Rep)JJN · Traditional | 09/08/1987SE |
| K871499 | Protofluor ZJKJ · Traditional | 08/25/1987SE |
| K872834 | Titan Gel Ife Antiserum to IGD-9409 & IGE-9410CZJ · Traditional | 08/12/1987SE |
| K872377 | Chrom-TrolJPA · Traditional | 07/09/1987SE |
| K871318 | Q.I.C. Bleeding Time DeviceJCA · Traditional | 06/10/1987SE |
| K870890 | Alkaline Phosphatase Indolyl Blue ReagentCIN · Traditional | 06/01/1987SE |
| K871498 | Titan Gel Immunofix ControlsDFT · Traditional | 04/29/1987SE |
| K870958 | Titan Gel Multi-Slot SP-17 Kit Cat. No. 3091CEF · Traditional | 04/29/1987SE |
| K871352 | Pentavalent Antiserum to Human ImmunoglobulinsDEW · Traditional | 04/22/1987SE |
| K871319 | Titan Gel Multi-Slot LIPO-17 SystemJHO · Traditional | 04/22/1987SE |
| K860645 | Electrophoresis Data Center (Edc)JQT · Traditional | 12/17/1986SE |
| K861414 | Electrophoresis Work Center (Ewc)JJN · Traditional | 08/26/1986SE |
| K862701 | SurespotJQW · Traditional | 08/19/1986SE |
| K860309 | Hemafluor Reagent KitKHO · Traditional | 07/14/1986SE |
| K861750 | Ck/Ld Buffer (Cat. No. 5808)CFE · Traditional | 05/29/1986SE |
| K861490 | Permaclear Solution Cat. No. 4950KEM · Traditional | 05/06/1986SE |
| K852392 | Edc/Titan Geliso-Total CPK Isoenzyme ProcedureCGS · Traditional | 10/22/1985SE |
| K852391 | Edc/Titan Geliso-Dot Total LDH Isoenzyme ProcedureCFH · Traditional | 10/01/1985SE |
| K851669 | Monitor IV PlusJOZ · Traditional | 07/23/1985SE |
| K843352 | Coloscreen Self-TestKHE · Traditional | 12/05/1984SE |
| K842669 | Titan Gel Iso Dot LDH KitCFE · Traditional | 11/09/1984SE |
| K842689 | Glyco-Tek Affinity ColumnLCP · Traditional | 10/15/1984SE |
| K842755 | Titan Gel Iso Dot CPK ProcedureCGS · Traditional | 09/28/1984SE |
| K840903 | Helena Coloscreen Self-TestKHE · Traditional | 08/10/1984SE |
| K841020 | Fibrinogen Assay KitKQJ · Traditional | 05/02/1984SE |
| K840848 | BiosureJJW · Traditional | 05/01/1984SE |
| K840329 | Ristocetin Cofactor AssayGGP · Traditional | 04/05/1984SE |
| K833611 | Titan Gel Lipoprotein ElectrophoresisJHO · Traditional | 03/15/1984SE |
| K833855 | Titan Gel Silver Stain SystemCEF · Traditional | 02/27/1984SE |
| K833772 | Auto Aic Analyzer SystemLCP · Traditional | 01/18/1984SE |
| K834456 | Helena Bio Strip ObKHE · Traditional | 01/13/1984SE |
| K833639 | Titangel High Resolution ControlJJY · Traditional | 01/04/1984SE |
| K834031 | Factor II Deficient Substrate PlasmaGGP · Traditional | 12/16/1983SE |
| K832864 | Coloscreen V.P.I.KHE · Traditional | 11/21/1983SE |
| K833356 | Glyco-Je,E Cpmtrp;-Normal/AbnormalLCP · Traditional | 11/03/1983SE |
| K832428 | Platelet Aggregation Reagent SetGHR · Traditional | 10/20/1983SE |
| K832496 | Bio Sure StainIDA · Traditional | 09/12/1983SE |
| K832087 | Titan Gel Glyco-Heme SystemLCP · Traditional | 08/24/1983SE |
| K831994 | Biocheck Positive Urine ControlJJW · Traditional | 08/08/1983SE |
| K831603 | Titan Ge/IeplateJZR · Traditional | 07/07/1983SE |
| K830978 | Helena Biostrip aJMA · Traditional | 05/13/1983SE |
| K830979 | Helena Biostrip PHCEN · Traditional | 05/05/1983SE |
| K830976 | Helena Biostrip KJIN · Traditional | 05/04/1983SE |
| K830977 | Helena Biostrip PJIR · Traditional | 04/28/1983SE |
| K830872 | Titan Gel LDH Iso-Enzyme ControlCFE · Traditional | 04/12/1983SE |
| K830834 | Negative Urine ControlJJW · Traditional | 04/12/1983SE |
| K830331 | Liquid Thromboplastin ReagentGJS · Traditional | 04/05/1983SE |
| K830320 | Activat-Partial Thrombo-PlastinGGW · Traditional | 04/05/1983SE |
| K830594 | Titan Immuno-FixDEW · Traditional | 03/24/1983SE |
| K823870 | Beta Thalquik Column #5341JPD · Traditional | 02/01/1983SE |
| K823869 | Glyco HB Quik Column ProcedureLCP · Traditional | 02/01/1983SE |
| K823267 | Factor Viii Related Antigen Rocket EidGGP · Traditional | 12/28/1982SE |
| K821983 | Titan Gel LDH Isoenzyme KitCEX · Traditional | 12/22/1982SE |
| K822124 | Titan Gel CPK Isoenzyme SystemJHT · Traditional | 11/01/1982SE |
| K822050 | Stirring Assembly for Digispec X SpectroJJQ · Traditional | 08/27/1982SE |
| K821982 | Titan Gel Serum ControlJJY · Traditional | 08/16/1982SE |
| K822123 | Isopropanol Hemoglobin Stability TestGKA · Traditional | 08/05/1982SE |
| K822026 | Immuno Diagnostics AssayCZP · Traditional | 08/03/1982SE |
| K821981 | Titan Gel Cpk/Ldh Isoenzyme ControlJJT · Traditional | 07/22/1982SE |
| K821688 | Titan Gel High Resolution Serum ProteinJJN · Traditional | 06/22/1982SE |
| K821517 | Titanan Gel Serum Protein ElectrophoresJJN · Traditional | 06/10/1982SE |
| K820772 | Fetal-Tek Control (Immature/Borderline)JJX · Traditional | 05/12/1982SE |
| K820594 | Biostrip GJIL · Traditional | 05/05/1982SE |
| K820787 | Helena Abnormal HBA2 Quik Column ControlJCM · Traditional | 04/08/1982SE |
| K820573 | Helena Hemoglobin Detect Column SysGKA · Traditional | 04/01/1982SE |
| K820437 | Aves Wright StainIAF · Traditional | 03/26/1982SE |
| K820319 | Fetal-Tek Control MatureJJS · Traditional | 03/25/1982SE |
| K813395 | Cellulose Acetate-Citrate Agar HemogloJBD · Traditional | 12/31/1981SE |
| K812428 | Helena Coloscreen MethodKHE · Traditional | 10/23/1981SE |
| K812226 | Helena HBF Quiplate ControlKQI · Traditional | 09/01/1981SE |
| K812077 | Helena Sickle-Thal Quik Column MethodJPD · Traditional | 08/18/1981SE |
| K811912 | Helena Vma-Smc ControlJJX · Traditional | 07/23/1981SE |
| K811777 | Helena Plasminogen Quiplate ProcedureDDX · Traditional | 07/02/1981SE |
| K811695 | Helena Fetal-Tek 200 MarkerJJY · Traditional | 07/01/1981SE |
| K811588 | Helena Fetal-Tek 200 MethodJHG · Traditional | 06/25/1981SE |
| K810992 | Helena Vma-Smc Column MethodCDF · Traditional | 04/29/1981SE |
| K810475 | Helena Hemoglobin F ControlsKQI · Traditional | 03/26/1981SE |
| K803281 | Automated Electrophoresis SystemJJN · Traditional | 01/16/1981SE |
| K803108 | Helena HBA2 Quik Column MethodJPD · Traditional | 01/09/1981SE |
| K803016 | Helena Hemespec II Total Hemoglobin Met.GKR · Traditional | 12/30/1980SE |
| K803015 | Hemespec IIGKR · Traditional | 12/30/1980SE |
| K802912 | Helena At-Iii Quiplate ProcedureJBQ · Traditional | 12/22/1980SE |
| K802232 | Ab-Trol Coagulation ControlGGW · Traditional | 11/12/1980SE |
| K802233 | Glycosylated Hemoglobin-Smc ColumnLCP · Traditional | 10/10/1980SE |
| K802109 | Kemtrol Serum Control AbnormalJJY · Traditional | 10/10/1980SE |
| K802108 | Kemtrol Serum Control-NormalJJY · Traditional | 10/10/1980SE |
| K800857 | Helena Glycosylated Hemoglobin Quik MethLCP · Traditional | 09/26/1980SE |
| K801932 | Hep-TrolGGW · Traditional | 09/09/1980SE |
| K801318 | Helena Ultra Sensitive CPK Reagent/DilueJHX · Traditional | 07/14/1980SE |
| K800852 | Hemespec Check SetKRZ · Traditional | 05/02/1980SE |
| K800433 | Helena ColocheckKHE · Traditional | 05/02/1980SE |
| K800856 | A,FDA2 Lyophilized Hemo ControlJBD · Traditional | 04/29/1980SE |
| K800855 | A,Fsc Lyophilized Hemo ControlJBD · Traditional | 04/29/1980SE |
| K800854 | A,A2 Lyophilized Hemo ControlJBD · Traditional | 04/29/1980SE |
| K800853 | A,SA2 Lyophilized Hemo ControlJBD · Traditional | 04/29/1980SE |
| K800432 | Helena RistocetinJOZ · Traditional | 03/25/1980SE |
| K792656 | Helena Factor Xii DeficientGGP · Traditional | 01/24/1980SE |
| K792655 | Helena ColoscreenKHE · Traditional | 01/24/1980SE |
| K792511 | Helena Factor Vii Deficient Sub. PlasmaGGP · Traditional | 12/31/1979SE |
| K792508 | Helena Factor X Deficient SubstrateGGP · Traditional | 12/31/1979SE |
| K792507 | Helena Factor V Deficient SubstrateGGP · Traditional | 12/31/1979SE |
| K792476 | Helena Factor Xi Deficient SubstrateGGP · Traditional | 12/31/1979SE |
| K792475 | Helena Factor Ix Deficient SubstrateGGP · Traditional | 12/31/1979SE |
| K792336 | Helena Factor II Deficient Sub. PlasmaGGP · Traditional | 12/27/1979SE |
| K792335 | Helena Factor Viii Deficient Sub. PlasmaGGP · Traditional | 12/04/1979SE |
| K792310 | Norm-TrolJPA · Traditional | 12/04/1979SE |
| K792025 | Lyophilized HDL Cholesterol ControlsJJY · Traditional | 10/30/1979SE |
| K792024 | LipotrolJJY · Traditional | 10/30/1979SE |
| K791315 | Spectro-Sur SetJIS · Traditional | 08/16/1979SE |
| K791144 | BufferizerJJN · Traditional | 08/03/1979SE |
| K791135 | Lyophilized G-Hb Quik Column ControlLCP · Traditional | 06/28/1979SE |
| K790798 | Fetal Maturity Test ProcedureJHG · Traditional | 06/05/1979SE |
| K790826 | Coagulation ArpJPK · Traditional | 05/31/1979SE |
| K790646 | Helena Quiplate SystemJZQ · Traditional | 05/23/1979SE |
| K790583 | Quik Column MethodologyLCP · Traditional | 04/23/1979SE |
| K790046 | G-Hb Quik Column ControlLCP · Traditional | 01/26/1979SE |
| K782035 | HemespecJJQ · Traditional | 01/17/1979SE |
| K780807 | Hbf-Quiplate MethodologyJBD · Traditional | 06/02/1978SE |
| K780256 | HDL Cholesterol MethodJHO · Traditional | 03/28/1978SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1975-2023 Class II | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus…Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18… | 05/02/2023Open, Classified |
| Z-1244-2022 Class II | V8 Immunodisplacement Kit REF 1803Due to microbial growth causing interference with interpretation. | 04/06/2022Open, Classified |
| Z-1108-2021 Class II | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo…Intermittent potential for shorter than expected clot times. | 01/05/2021Terminated |
| Z-0635-2021 Class II | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING…Due to complaints received associated with cracked/split test tube caps. | 11/09/2020Open, Classified |
| Z-1950-2019 Class II | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The…The positive control on some tests of the lots did not appropriately react within the specified timeframe to… | 08/08/2018Open, Classified |
| Z-1949-2019 Class II | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The…The positive control on some tests of the lots did not appropriately react within the specified timeframe to… | 08/08/2018Open, Classified |
| Z-0537-2020 Class III | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies…Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent… | 05/23/2018Open, Classified |
| Z-0536-2020 Class III | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies…Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent… | 05/23/2018Open, Classified |
| Z-0297-2020 Class III | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation…Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The… | 02/27/2018Open, Classified |
| Z-2761-2019 Class II | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label…Some of the cards show occasional shorter clot times than the expected variation resulting in a potential… | 12/07/2017Terminated |
| Z-0045-2020 Class II | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name…The plates do not have wells punched for the controls in the patient 1 area. | 07/21/2017Terminated |
| Z-0106-2019 Class II | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free…Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S… | 04/04/2017Terminated |
| Z-0561-2019 Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C…Due to some cards in this lot reported to have experienced variations in results, (verified by wave form)… | 02/24/2017Terminated |
| Z-0529-2019 Class III | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme…Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12%… | 11/07/2016Terminated |
| Z-2434-2019 Class II | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mLDue to customer-experienced complaints on narrow assay range compared to prior lots and the user being out… | 10/14/2016Terminated |
| Z-0594-2019 Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C…Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or… | 04/20/2016Terminated |