Mixture, Hematology Quality Control
FDA product code JPK · Class II (moderate risk) · 21 CFR 864.8625 · Hematology
192510(k) clearances
0PMA approvals
13recalls
Manufacturers
- R&D Systems, Inc. 45
- Streck Laboratories, Inc. 23
- Streck 12
- Beckman Coulter Inc. 10
- Coulter Electronics, Inc. 8
- Bhp Diagnostix, Inc. 7
- Hematronix, Inc. 6
- Medical Specialties, Inc. 5
- American Dade 5
- Fisher Scientific Co., LLC 5
- Coulter Corp. 5
- Hematology Marketing Assoc. 4
- Technicon Instruments Corp. 3
- Ortho Instruments 3
- Diagnostic Technology, Inc. 3
- Bio-Rad 3
- Bioscientific 3
- Bd Becton Dickinson Vacutainer Systems Preanalytic 3
- Dade, Baxter Travenol Diagnostics, Inc. 3
- Helena Laboratories 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160590 | XN CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | Streck | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160606 | BC-5D Hematology ControlJPK · Traditional | R&D Systems, Inc. | 09/01/2016SE |
| K141964 | XN CheckJPK · Traditional | Streck | 12/05/2014SE |
| K141957 | XN Check BFJPK · Traditional | Streck | 12/05/2014SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | R&D Systems, Inc. | 07/24/2013SE |
| K120744 | XN Check BFJPK · Traditional | Streck | 10/19/2012SE |
| K120742 | XN CheckJPK · Traditional | Streck | 10/19/2012SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/28/2011SE |
| K100790 | Coulter Lin-X Linearity Control, Model A81196JPK · Traditional | Beckman Coulter, Inc. | 12/21/2010SE |
| K100607 | Coulter 4C-EX 300 Cell ControlJPK · Traditional | Beckman Coulter, Inc. | 11/18/2010SE |
| K091303 | Liquichek HEMATOLOGY-16 Control LV, Model: 295LVJPK · Traditional | Bio-Rad Laboratories | 08/02/2010SE |
| K100050 | R & D Systems Xeret Hematology ControlJPK · Special | R&D Systems, Inc. | 01/29/2010SE |
| K091433 | R&D Systems Tetic-I Plus Hemotology ControlJPK · Special | R&D Systems, Inc. | 10/28/2009SE |
| K090201 | Ua-Cellular for IqJPK · Traditional | Streck | 03/27/2009SE |
| K082162 | Coulter Body Fluid ControlJPK · Traditional | Beckman Coulter, Inc. | 02/03/2009SE |
| K081822 | Coulter 6C Cell Control, Models 628027 & A59925JPK · Traditional | Beckman Coulter, Inc. | 01/21/2009SE |
| K081641 | Coulter Lin-X Linearity ControlJPK · Traditional | Beckman Coulter, Inc. | 01/16/2009SE |
| K073178 | HCT Extended Hematology Control, Model HCT004JPK · Traditional | R&D Systems, Inc. | 12/27/2007SE |
| K072846 | CSF Automated Control, Models CSF001, CSF003JPK · Traditional | R&D Systems, Inc. | 11/26/2007SE |
| K072268 | HC WBC Hematology Control, Model: WBC00SJPK · Traditional | R&D Systems, Inc. | 11/20/2007SE |
| K072096 | CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04JPK · Special | R&D Systems, Inc. | 08/20/2007SE |
| K070199 | Retic-Chex Linearity for BCJPK · Traditional | Streck | 02/23/2007SE |
| K063218 | E-Check (Xe)JPK · Traditional | Streck | 12/14/2006SE |
| K061511 | R&D CBC-3D + CRP Hematology ControlJPK · Special | R&D Systems, Inc. | 07/10/2006SE |
| K061320 | R&D Lh-Nrbc Hematology ControlJPK · Special | R&D Systems, Inc. | 06/02/2006SE |
| K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503JPK · Traditional | Beckman Coulter, Inc. | 05/17/2006SE |
| K060464 | Coulter 5C Cell ControlJPK · Traditional | Beckman Coulter, Inc. | 03/28/2006SE |
| K053362 | Cell-Chex AutoJPK · Traditional | Streck | 01/13/2006SE |
| K051706 | Iq Body Fluids ControlJPK · Traditional | Streck | 08/17/2005SE |
| K051339 | R&D CBC-4K Plus Retics Hematology ControlJPK · Special | R&D Systems, Inc. | 07/12/2005SE |
| K050721 | Abx ErytrolJPK · Traditional | Horiba Abx | 06/01/2005SE |
| K042836 | Liquichek Reticulocyte Control (a)JPK · Traditional | Bio-Rad | 11/05/2004SE |
| K042587 | Retic-Chex for Cell-DynJPK · Traditional | Streck Laboratories, Inc. | 10/19/2004SE |
| K042336 | Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel MinipakJPK · Traditional | Bio-Rad Laboratories, Inc. | 10/14/2004SE |
| K042094 | R&D Cbc-Xe Hematology ControlJPK · Special | R&D Systems, Inc. | 09/01/2004SE |
| K041457 | Liquichek Hematology Control (a)JPK · Traditional | Bio-Rad | 06/28/2004SE |
| K024173 | CDS 3-PD Hematology ControlsJPK · Traditional | Clinical Diagnostic Solutions, Inc. | 01/14/2003SE |
| K022968 | Advia Testpoint CSF ControlJPK · Traditional | Bayer Diagnostics Corp. | 09/24/2002SE |
| K021922 | Modification to Para 5XJPK · Special | Streck Laboratories, Inc. | 06/25/2002SE |
| K020229 | R & D Body Fluid ControlJPK · Traditional | R&D Systems, Inc. | 02/06/2002SE |
| K013898 | R&D Ret-Line KitJPK · Traditional | R&D Systems, Inc. | 01/22/2002SE |
| K013842 | Immuno-Trol Low CellsJPK · Traditional | Beckman Coulter, Inc. | 12/13/2001SE |
| K011410 | Para 5XJPK · Traditional | Streck Laboratories, Inc. | 06/26/2001SE |
| K010470 | R & D 4K ReticJPK · Traditional | R&D Systems, Inc. | 05/11/2001SE |
| K010461 | Advia Retic PlusJPK · Traditional | R&D Systems, Inc. | 04/03/2001SE |
| K010598 | Synovialscopics, Synovial Fluid ControlJPK · Traditional | Quantimetrix Corp. | 03/23/2001SE |
| K010409 | Cbc-SfJPK · Traditional | R&D Systems, Inc. | 03/16/2001SE |
| K010066 | 5C-ES Cell Control, Models 7547191, 7547192JPK · Special | Beckman Coulter, Inc. | 02/07/2001SE |
| K010064 | 4C-ES Cell, Models 7547187, 7547188, 7547189, 7547190JPK · Special | Beckman Coulter, Inc. | 02/07/2001SE |
| K003874 | CBC-4K Hematology ControlJPK · Special | R&D Systems, Inc. | 01/12/2001SE |
| K003534 | Pentra 5DJPK · Traditional | R&D Systems, Inc. | 12/01/2000SE |
| K003208 | R & D 3K ReticJPK · Special | R&D Systems, Inc. | 11/07/2000SE |
| K002511 | FetaltrolJPK · Traditional | Trillium Diagnostics, LLC | 09/11/2000SE |
| K000115 | Retic Chex LinearityJPK · Traditional | Streck Laboratories, Inc. | 03/27/2000SE |
| K993496 | Retic-QuinoxJPK · Traditional | Hematronix, Inc. | 11/30/1999SE |
| K991876 | Sedrite Plus Erythrocyte Sedimentation RateJPK · Traditional | R&D Systems, Inc. | 06/17/1999SE |
| K984216 | Immuno-Trol Control CellsJPK · Traditional | Coulter Corp. | 03/16/1999SE |
| K983032 | CBC-5D Hematology ControlJPK · Traditional | R&D Systems, Inc. | 02/17/1999SE |
| K984099 | QBC Centrifugal Hematology ControlJPK · Special | R&D Systems, Inc. | 12/10/1998SE |
| K972172 | Esr Control-M Hematology Erythrocyte SedimentationJPK · Traditional | R&D Systems, Inc. | 07/24/1997SE |
| K972170 | Esr Control-Hc Hematology Erythrocyte SedimentationJPK · Traditional | R&D Systems, Inc. | 07/24/1997SE |
| K971469 | Coulter Act Tron Cell ControlJPK · Traditional | Coulter Corp. | 06/30/1997SE |
| K970331 | CBC-4K Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/16/1997SE |
| K961673 | R&D Retic-Pg Hematology ControlJPK · Traditional | R&D Systems, Inc. | 07/15/1996SE |
| K960557 | Calibration Verification Assessment (Cva)JPK · Traditional | Streck Laboratories, Inc. | 04/03/1996SE |
| K960471 | Tri-Count 20JPK · Traditional | Hematronix, Inc. | 03/20/1996SE |
| K960005 | Tri-Court 20-TJPK · Traditional | Hematronix, Inc. | 03/19/1996SE |
| K955334 | Coulter Linearity ControlJPK · Traditional | Coulter Corp. | 02/08/1996SE |
| K955016 | 4C Plus Coulter Cell ControlJPK · Traditional | Coulter Corp. | 01/30/1996SE |
| K954137 | QBC Centrifugal Hematology ControlJPK · Traditional | R&D Systems, Inc. | 10/06/1995SE |
| K952720 | Aalto Scientific Ltd. Glycated Hemoglobin Control Levels I & IIJPK · Traditional | Aalto Scientific, Ltd. | 09/20/1995SE |
| K952245 | Sf-CheckJPK · Traditional | Streck Laboratories, Inc. | 09/01/1995SE |
| K941965 | Ez-RangeJPK · Traditional | Hematronix, Inc. | 04/25/1995SE |
| K943336 | Retic Control-H Hematology Control/MultipleJPK · Traditional | R&D Systems, Inc. | 12/12/1994SE |
| K943335 | Retic Control-M Hematology Control/MultipleJPK · Traditional | R&D Systems, Inc. | 12/12/1994SE |
| K944751 | Coulter Flow SetJPK · Traditional | Coulter Corp. | 12/08/1994SE |
| K942822 | Cbc-Line Hematology Linearity ControlJPK · Traditional | R&D Systems, Inc. | 10/07/1994SE |
| K935196 | Para 5 DiffJPK · Traditional | Streck Laboratories, Inc. | 04/05/1994SE |
| K940089 | Cbc-Cobas 5 Hematology Control/MultipleJPK · Traditional | R&D Systems, Inc. | 03/22/1994SE |
| K940181 | Se-CheckJPK · Traditional | Streck Laboratories, Inc. | 03/09/1994SE |
| K935343 | Centrifiq Blood ControlJPK · Traditional | Hematronix, Inc. | 01/27/1994SE |
| K931947 | CheckpointJPK · Traditional | Medical Specialties, Inc. | 06/18/1993SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | Coulter Electronics, Inc. | 04/05/1993SE |
| K923971 | Qc-ChexJPK · Traditional | Streck Laboratories, Inc. | 11/16/1992SE |
| K914099 | Gas Trak Connect Blood Gas ControlJPK · Traditional | Biochemical Sciences, Inc. | 12/18/1991SE |
| K913879 | CBC-8K(TM) Hematology Control/MultipleJPK · Traditional | R&D Systems, Inc. | 11/27/1991SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | Coulter Electronics, Inc. | 07/17/1991SE |
| K905524 | Retic-ChexJPK · Traditional | Streck Laboratories, Inc. | 02/20/1991SE |
| K904637 | Qbc(R) Centrifugal Hematology Control/MultipleJPK · Traditional | R&D Systems, Inc. | 10/29/1990SE |
| K904461 | Meter TraxJPK · Traditional | Hematronix, Inc. | 10/26/1990SE |
| K904464 | Cbc-Laser(R) Hematology Control/Multiple-ModifiedJPK · Traditional | R&D Systems, Inc. | 10/23/1990SE |
| K900017 | Rep Glyco Control NORMAL(3209) and ABNORMAL(3210)JPK · Traditional | Helena Laboratories | 01/29/1990SE |
| K893895 | Hematology Control Mixtures for Quality ControlJPK · Traditional | Intercare Diagnostics, Inc. | 07/25/1989SE |
| K884266 | PH Blood Gas Control ProductsJPK · Traditional | Alko Diagnostic Corp. | 05/16/1989SE |
| K890767 | Ne-CheckJPK · Traditional | Streck Laboratories, Inc. | 03/23/1989SE |
| K890749 | Cbc-Tech (TM) Hematology Control/MultipleJPK · Traditional | R&D Systems, Inc. | 02/27/1989SE |
| K880270 | Msi-Diff PlusJPK · Traditional | Medical Specialties, Inc. | 03/01/1988SE |
| K873354 | QBC Venous Blood Control/MultipleJPK · Traditional | R&D Systems, Inc. | 09/29/1987SE |
| K871067 | Msi Hematology Control +JPK · Traditional | Medical Specialties, Inc. | 03/25/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | Fisher Scientific Co., LLC | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | Fisher Scientific Co., LLC | 07/10/1986SE |
| K862186 | Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&IiJPK · Traditional | Bio-Rad | 07/01/1986SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | Bio/Data Corp. | 03/18/1986SE |
| K854353 | Platelet-Trol IIJPK · Traditional | R&D Systems, Inc. | 11/26/1985SE |
| K852992 | Para Check (Aka Eight Check-C)JPK · Traditional | Streck Laboratories, Inc. | 10/10/1985SE |
| K853776 | Msi-Hb Hemoglobin ControlJPK · Traditional | Medical Specialties, Inc. | 09/19/1985SE |
| K852372 | Cell-Dyn Brand Hematology ReagentsJPK · Traditional | Abbott Diagnostics | 09/03/1985SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | Seragen Diagnostics, Inc. | 07/23/1985SE |
| K851375 | Tri-CountJPK · Traditional | Hematology Marketing Assoc. | 07/12/1985SE |
| K850755 | CBC-PLT-4/MULTIPLE Whole Blood Hematology ControlJPK · Traditional | R&D Systems, Inc. | 05/13/1985SE |
| K850250 | Technicon Testpoint Assayed Hematology Low & HighJPK · Traditional | Technicon Instruments Corp. | 04/01/1985SE |
| K844928 | Quanticel HHR Two Human Hematology ReferenceJPK · Traditional | Bhp Diagnostix, Inc. | 03/22/1985SE |
| K844927 | Quanticel HHR + Two Human Hematology W/PlateletsJPK · Traditional | Bhp Diagnostix, Inc. | 03/22/1985SE |
| K844897 | Hematology Control Uni-Cell 5, Uni-Cell 7 & 8JPK · Traditional | Medical Specialties Laboratories | 03/22/1985SE |
| K843805 | Coulter Check Sample Unassayed HematologJPK · Traditional | Coulter Electronics, Inc. | 12/17/1984SE |
| K843485 | Tri-Count LaserJPK · Traditional | Hematology Marketing Assoc. | 12/12/1984SE |
| K841809 | Count-A-Part PlusJPK · Traditional | Diagnostic Technology, Inc. | 11/30/1984SE |
| K843962 | CBC-PLT-4 Whole Blood Control/MultipleJPK · Traditional | R&D Systems, Inc. | 11/01/1984SE |
| K843093 | Retic-ChexJPK · Traditional | Streck Laboratories, Inc. | 10/23/1984SE |
| K842286 | Dia T1, T2 & T3JPK · Traditional | Diatech, Inc. | 09/11/1984SE |
| K842440 | Sickle Cell Stat A/S Heterozygous-ErythJPK · Traditional | Anco Medical Reagents & Assoc. | 07/27/1984SE |
| K842109 | Technicon Test Point Assayed HematologyJPK · Traditional | Technicon Instruments Corp. | 07/27/1984SE |
| K841531 | Para-TekJPK · Traditional | Streck Laboratories, Inc. | 07/27/1984SE |
| K842017 | Para 4JPK · Traditional | Streck Laboratories, Inc. | 06/26/1984SE |
| K841239 | Assigned Value for Mean PlateletJPK · Traditional | Coulter Electronics, Inc. | 05/02/1984SE |
| K840302 | PLT - 4 PlateletJPK · Traditional | R&D Systems, Inc. | 03/12/1984SE |
| K834371 | Tri-Count 10JPK · Traditional | Hematology Marketing Assoc. | 03/09/1984SE |
| K834043 | Msi-Hc Hematology ControlJPK · Traditional | Medical Specialties, Inc. | 01/03/1984SE |
| K833563 | HC PlusJPK · Traditional | Coulter Electronics, Inc. | 01/03/1984SE |
| K833130 | Tri-Count 7JPK · Traditional | Hematology Marketing Assoc. | 10/20/1983SE |
| K831704 | Technicon H6000 System ControlJPK · Traditional | Technicon Instruments Corp. | 07/06/1983SE |
| K830864 | White Blood Cell ControlJPK · Traditional | Control Diagnostics | 06/15/1983SE |
| K831094 | Para LasarJPK · Traditional | Streck Laboratories, Inc. | 06/08/1983SE |
| K820731 | Hematall-C Plus Hematology ControlsJPK · Traditional | Fisher Scientific Co., LLC | 05/12/1982SE |
| K820401 | Ortho* Hematology Contr. 8 Abn. Hi/LowJPK · Traditional | Orhto Diagnostic Systems, Inc. | 03/15/1982SE |
| K820400 | Ortho* Hematology Control 8 NormalJPK · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1982SE |
| K812280 | Hematology ControlJPK · Traditional | American Dade | 09/09/1981SE |
| K812237 | Hemotology Quality Control MixtureJPK · Traditional | American Dade | 09/09/1981SE |
| K812357 | Ventrex Data Reduction & Qual. Contr. SyJPK · Traditional | Ventrex Laboratories, Inc. | 09/01/1981SE |
| K810756 | Hemotology Quality Control MixturesJPK · Traditional | Scientific Standards, Inc. | 06/30/1981SE |
| K801054 | Thrombo-Test (X)JPK · Traditional | Medtro GmbH | 03/13/1981SE |
| K803084 | Ortho Hematology Control Abnormal LowJPK · Traditional | Ortho Instruments | 12/31/1980SE |
| K803083 | Ortho Hemotology Control-NormalJPK · Traditional | Ortho Instruments | 12/31/1980SE |
| K803073 | Ortho Hematology ControlJPK · Traditional | Ortho Instruments | 12/31/1980SE |
| K802267 | PLT-4 Size-CheckJPK · Traditional | R&D Systems, Inc. | 11/12/1980SE |
| K802265 | CBC PLT-4JPK · Traditional | R&D Systems, Inc. | 11/12/1980SE |
| K802143 | CH-60 Plus /Abnormal Low/Blood PlateletJPK · Traditional | American Dade | 10/10/1980SE |
| K802142 | CH-60 Plus Whole Blood Platelet/AbnornalJPK · Traditional | American Dade | 10/10/1980SE |
| K802141 | CH-60 Plus Whole Blood Platelet ControlJPK · Traditional | American Dade | 10/10/1980SE |
| K801267 | Red Blood Cell Count & Hematocrit CNTLJPK · Traditional | Bioscientific | 07/14/1980SE |
| K801265 | White Blood Cell Count Control LevelsJPK · Traditional | Bioscientific | 07/14/1980SE |
| K800938 | Tri-CheckJPK · Traditional | Scientific Standards, Inc. | 05/08/1980SE |
| K800780 | Sandare Lyophilized Hemoglobin ControlsJPK · Traditional | Sandare Chemical Co., Inc. | 04/24/1980SE |
| K800361 | Hemato-ChexJPK · Traditional | Streck Laboratories, Inc. | 04/04/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 02/13/1980SE |
| K792467 | Platelet-Chex for Blood CentersJPK · Traditional | Streck Laboratories, Inc. | 12/31/1979SE |
| K792209 | Sandare Hemoglobin ControlsJPK · Traditional | Sandare Chemical Co., Inc. | 12/04/1979SE |
| K792055 | Fisher Diagnostics Hematology ControlsJPK · Traditional | Fisher Scientific Co., LLC | 11/05/1979SE |
| K791772 | Counter-Check Plus Normal, High Abn.JPK · Traditional | Diagnostic Technology, Inc. | 10/11/1979SE |
| K791750 | Counter-Check PlusJPK · Traditional | Diagnostic Technology, Inc. | 10/11/1979SE |
| K791228 | PARA-8JPK · Traditional | Streck Laboratories, Inc. | 08/03/1979SE |
| K791227 | PARA-7JPK · Traditional | Streck Laboratories, Inc. | 08/03/1979SE |
| K791226 | Platelet-Chex PlusJPK · Traditional | Streck Laboratories, Inc. | 08/03/1979SE |
| K791030 | Hemoglobin Af/Sc Electrophoresis ControlJPK · Traditional | Beckman Instruments, Inc. | 06/22/1979SE |
| K790826 | Coagulation ArpJPK · Traditional | Helena Laboratories | 05/31/1979SE |
| K790457 | Hemoglobin ControlsJPK · Traditional | Data Medical Associates, Inc. | 04/04/1979SE |
| K790415 | HCP-7JPK · Traditional | Bioscientific | 04/04/1979SE |
| K790525 | Hematrol S Hematology ControlsJPK · Traditional | Fisher Scientific Co., LLC | 04/03/1979SE |
| K781969 | Blood, Hematology Reference ControlJPK · Traditional | Coulter Electronics, Inc. | 01/03/1979SE |
| K781786 | Quanticel HHR # L500 and L501JPK · Traditional | Bhp Diagnostix, Inc. | 11/15/1978SE |
| K781745 | Quanticel HHR, L531 and L532JPK · Traditional | Bhp Diagnostix, Inc. | 11/15/1978SE |
| K781573 | Abnormal Hematology Control UnassayedJPK · Traditional | Ortho Diagnostics, Inc. | 10/17/1978SE |
| K781572 | Normal Hematology Control UnassayedJPK · Traditional | Ortho Diagnostics, Inc. | 10/17/1978SE |
| K781247 | Quanticel-HrpJPK · Traditional | Bhp Diagnostix, Inc. | 09/14/1978SE |
| K781077 | Control, Hematology, CH-60JPK · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 07/27/1978SE |
| K780980 | Platelet ControlJPK · Traditional | Bhp Diagnostix, Inc. | 07/27/1978SE |
| K780835 | ArantrolJPK · Traditional | Aranco Diagnostic Laboratories, Inc. | 06/22/1978SE |
| K780714 | Platelet ControlJPK · Traditional | Bhp Diagnostix, Inc. | 06/06/1978SE |
| K780140 | Cell-ChexJPK · Traditional | Streck Laboratories, Inc. | 03/27/1978SE |
| K772195 | Hematology Reference ControlsJPK · Traditional | R&D Systems, Inc. | 02/03/1978SE |
| K771753 | Hematology Reference ControlJPK · Traditional | Coulter Electronics, Inc. | 11/28/1977SE |
| K770384 | Mnitrol Hemotol. Ref. and ControlJPK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/08/1977SE |
| K770386 | Latelet, Control, Normal & AbnormalJPK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/21/1977SE |
| K770095 | Platelet Control, Normal & AbnormalJPK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/28/1977SE |
| K770020 | Platelet-Chex-HumanJPK · Traditional | Streck Laboratories, Inc. | 02/16/1977SE |
| K760682 | 4C Abnormal Low-High (8 X 6 M1)JPK · Traditional | Coulter Electronics, Inc. | 10/08/1976SE |
| K760597 | Biotrol-NormalJPK · Traditional | Boehringer Mannheim Corp. | 10/08/1976SE |
| K760596 | Biotrol-AbnormalJPK · Traditional | Boehringer Mannheim Corp. | 10/08/1976SE |
| K760549 | Platelet Controls, Normal & AbnormalJPK · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 10/08/1976SE |
| K760162 | Hematology ControlJPK · Traditional | Biological Corp. of America | 08/04/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0999-2023 Class III | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501…For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to… | R & D Systems, Inc. | 11/07/2022Terminated |
| Z-0350-2023 Class III | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part…The Control Level I material value was showing results exceeding the upper limit of the acceptable range… | Primus Corporation dba Trinity Biotech | 10/05/2021Terminated |
| Z-0349-2023 Class III | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for…The Control Level I material value was showing results exceeding the upper limit of the acceptable range… | Primus Corporation dba Trinity Biotech | 10/05/2021Terminated |
| Z-1249-2021 Class II | RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the…Product was compromised during shipment. | Medline Industries Inc | 01/25/2021Terminated |
| Z-0562-2021 Class II | BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete…Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may… | Becton, Dickinson and Company, BD Biosciences | 10/05/2020Terminated |
| Z-1436-2014 Class II | Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro…Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. | Clinical Diagnostic Solutions | 02/24/2013Terminated |
| Z-0429-2013 Class III | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low…HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high… | Horiba Instruments, Inc dba Horiba Medical | 09/14/2012Terminated |
| Z-0191-2013 Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part… | Clinical Diagnostic Solutions | 03/24/2011Terminated |
| Z-0190-2013 Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part… | Clinical Diagnostic Solutions | 03/24/2011Terminated |
| Z-0189-2013 Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part… | Clinical Diagnostic Solutions | 03/24/2011Terminated |
| Z-0194-2013 Class III | Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part… | Clinical Diagnostic Solutions | 08/04/2010Terminated |
| Z-0193-2013 Class III | Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor…Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part… | Clinical Diagnostic Solutions | 08/04/2010Terminated |
| Z-0516-2009 | Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | Quantimetrix Corporation | 06/01/2007Terminated |