R&D Systems, Inc.
Medical device manufacturer in Minneapolis, MN.
79510(k) clearances
0PMA approvals
6recalls
Device types
- JPK Mixture, Hematology Quality Control 45
- KRX Calibrator For Cell Indices 4
- GGT Assay, Erythropoietin 3
- GGM Control, Hemoglobin 3
- JCN Control, Cell Counter, Normal And Abnormal 3
- KSA Calibrator For Red-Cell And White-Cell… 3
- GKZ Counter, Differential Cell 2
- KQC Stains, Hematology 2
- KRY Calibrator For Platelet Counting 1
- JJX Single (Specified) Analyte Controls… 1
- JNM Immunochemical, Transferrin 1
- KRZ Calibrator For Hemoglobin And Hematocrit… 1
- GIF Diluent, Blood Cell 1
- GKH Apparatus, Automated Blood Cell Diluting 1
- KSQ Device, Blood Mixing And Blood Weighing 1
- FRZ Device, Patient Transfer, Powered 1
- JFB Table, Physical Therapy, Multi Function 1
- LIB Device, General Purpose, Microbiology… 1
- KJN Brilliant Cresyl Blue 1
- KHG Whole Blood Hemoglobin Determination 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K160606 | BC-5D Hematology ControlJPK · Traditional | 09/01/2016SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | 07/24/2013SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | 04/28/2011SE |
| K100050 | R & D Systems Xeret Hematology ControlJPK · Special | 01/29/2010SE |
| K091433 | R&D Systems Tetic-I Plus Hemotology ControlJPK · Special | 10/28/2009SE |
| K073178 | HCT Extended Hematology Control, Model HCT004JPK · Traditional | 12/27/2007SE |
| K072846 | CSF Automated Control, Models CSF001, CSF003JPK · Traditional | 11/26/2007SE |
| K072268 | HC WBC Hematology Control, Model: WBC00SJPK · Traditional | 11/20/2007SE |
| K072096 | CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04JPK · Special | 08/20/2007SE |
| K070334 | R&D Sickle QC ControlGGM · Traditional | 03/29/2007SE |
| K061511 | R&D CBC-3D + CRP Hematology ControlJPK · Special | 07/10/2006SE |
| K061320 | R&D Lh-Nrbc Hematology ControlJPK · Special | 06/02/2006SE |
| K051339 | R&D CBC-4K Plus Retics Hematology ControlJPK · Special | 07/12/2005SE |
| K042094 | R&D Cbc-Xe Hematology ControlJPK · Special | 09/01/2004SE |
| K034048 | R&D Glu-Line Hematology ControlJJX · Traditional | 03/10/2004SE |
| K020229 | R & D Body Fluid ControlJPK · Traditional | 02/06/2002SE |
| K013898 | R&D Ret-Line KitJPK · Traditional | 01/22/2002SE |
| K010470 | R & D 4K ReticJPK · Traditional | 05/11/2001SE |
| K010461 | Advia Retic PlusJPK · Traditional | 04/03/2001SE |
| K010409 | Cbc-SfJPK · Traditional | 03/16/2001SE |
| K003991 | Cd-Cal Plus CalibratorKRX · Special | 01/16/2001SE |
| K003874 | CBC-4K Hematology ControlJPK · Special | 01/12/2001SE |
| K003534 | Pentra 5DJPK · Traditional | 12/01/2000SE |
| K003208 | R & D 3K ReticJPK · Special | 11/07/2000SE |
| K993321 | R&D Hgb/Glc Whole Blood ControlGGM · Traditional | 11/12/1999SE |
| K991876 | Sedrite Plus Erythrocyte Sedimentation RateJPK · Traditional | 06/17/1999SE |
| K983032 | CBC-5D Hematology ControlJPK · Traditional | 02/17/1999SE |
| K984099 | QBC Centrifugal Hematology ControlJPK · Special | 12/10/1998SE |
| K982231 | StatusflowGKZ · Special | 07/20/1998SE |
| K972172 | Esr Control-M Hematology Erythrocyte SedimentationJPK · Traditional | 07/24/1997SE |
| K972170 | Esr Control-Hc Hematology Erythrocyte SedimentationJPK · Traditional | 07/24/1997SE |
| K964767 | Quantikine IVD BETA-2-MICROGLOBULIN Enzyme Immunoassay (Eia(JZG · Traditional | 05/29/1997SE |
| K970718 | Quantikine IVD STFR Enzyme Linked Immunosorbent Assay (Elisa)JNM · Traditional | 05/27/1997SE |
| K970331 | CBC-4K Hematology ControlJPK · Traditional | 04/16/1997SE |
| K961673 | R&D Retic-Pg Hematology ControlJPK · Traditional | 07/15/1996SE |
| K961610 | R & D Systems' Whole Blood Flow Control, (R & D - WBFC)GKZ · Traditional | 07/01/1996SE |
| K955925 | Cbc-Cal Plus Hematology CalibratorKRX · Traditional | 02/29/1996SE |
| K954137 | QBC Centrifugal Hematology ControlJPK · Traditional | 10/06/1995SE |
| K943336 | Retic Control-H Hematology Control/MultipleJPK · Traditional | 12/12/1994SE |
| K943335 | Retic Control-M Hematology Control/MultipleJPK · Traditional | 12/12/1994SE |
| K942822 | Cbc-Line Hematology Linearity ControlJPK · Traditional | 10/07/1994SE |
| K936016 | Quantikine IVD Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)GGT · Traditional | 07/19/1994SE |
| K931756 | Quantikine(Tm) Erythropoietin Human Serum ControlsGGT · Traditional | 04/21/1994SE |
| K940089 | Cbc-Cobas 5 Hematology Control/MultipleJPK · Traditional | 03/22/1994SE |
| K934497 | Cbc-Stk(Tm) Hematology Control/MultipleJCN · Traditional | 12/06/1993SE |
| K931666 | Quantikine(Tm) Erythropoietin/Enz Link Immun AssayGGT · Traditional | 07/20/1993SE |
| K913879 | CBC-8K(TM) Hematology Control/MultipleJPK · Traditional | 11/27/1991SE |
| K912357 | 3K-CAL Hematology Calibrator/MultipleKRX · Traditional | 07/09/1991SE |
| K904637 | Qbc(R) Centrifugal Hematology Control/MultipleJPK · Traditional | 10/29/1990SE |
| K904464 | Cbc-Laser(R) Hematology Control/Multiple-ModifiedJPK · Traditional | 10/23/1990SE |
| K897060 | Cbc-Cal(Tm) Plus Hematology Calibrator/MultipleKSA · Traditional | 01/02/1990SE |
| K893985 | Hgb-Control Set/MultipleGGM · Traditional | 08/15/1989SE |
| K893984 | Hgb-Cal Set/MultipleKRZ · Traditional | 08/15/1989SE |
| K891907 | Qbc(R) Centrifugal Hematology Contr/Multi ModifiedJCN · Traditional | 04/11/1989SE |
| K890749 | Cbc-Tech (TM) Hematology Control/MultipleJPK · Traditional | 02/27/1989SE |
| K882490 | Hycel Quick-Lysing Hemoglobin ReagentGIF · Traditional | 07/25/1988SE |
| K881161 | Tech-Cal(Tm)/MultipleKSA · Traditional | 05/02/1988SE |
| K874386 | Cbc-Tech(Tm) Hematology Control/MultipleJCN · Traditional | 12/30/1987SE |
| K873354 | QBC Venous Blood Control/MultipleJPK · Traditional | 09/29/1987SE |
| K862858 | Cbc-Cal (TM) Plus/MultipleKRX · Traditional | 08/21/1986SE |
| K854823 | Cbc-Cal/MultipleKSA · Traditional | 02/13/1986SE |
| K854353 | Platelet-Trol IIJPK · Traditional | 11/26/1985SE |
| K852016 | Laser Plateletcal/MultipleKRY · Traditional | 07/09/1985SE |
| K850755 | CBC-PLT-4/MULTIPLE Whole Blood Hematology ControlJPK · Traditional | 05/13/1985SE |
| K843962 | CBC-PLT-4 Whole Blood Control/MultipleJPK · Traditional | 11/01/1984SE |
| K843619 | Retic-SetKQC · Traditional | 10/30/1984SE |
| K842747 | Hycel Dilutor, Various Models/MultiGKH · Traditional | 10/01/1984SE |
| K842746 | Hycel Rotor-Mixer And/Or MultiKSQ · Traditional | 08/17/1984SE |
| K841848 | Retic-SetKQC · Traditional | 05/31/1984SE |
| K834585 | Celltrak-BFRZ · Traditional | 05/02/1984SE |
| K840302 | PLT - 4 PlateletJPK · Traditional | 03/12/1984SE |
| K832464 | Massage Table AAT-100JFB · Traditional | 08/16/1983SE |
| K831448 | Spia Sys for Solid Phase ImmunoassaysLIB · Traditional | 06/08/1983SE |
| K821318 | Retic SetKJN · Traditional | 06/02/1982SE |
| K802268 | Crc(Cyanmethemoglobin Reagent ConcentKHG · Traditional | 12/31/1980SE |
| K802267 | PLT-4 Size-CheckJPK · Traditional | 11/12/1980SE |
| K802265 | CBC PLT-4JPK · Traditional | 11/12/1980SE |
| K802266 | HGB3 (1:251)GKR · Traditional | 10/23/1980SE |
| K772195 | Hematology Reference ControlsJPK · Traditional | 02/03/1978SE |
Recalls
| Recall | Product | 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… | 11/07/2022Terminated |
| Z-1390-2022 Class III | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for…The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an… | 06/14/2022Completed |
| Z-1255-2021 Class II | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological…R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the… | 01/20/2021Terminated |
| Z-0691-2019 Class III | Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM…The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control… | 11/01/2018Terminated |
| Z-0410-2019 Class III | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label… | 09/11/2018Terminated |
| Z-2887-2016 Class II | R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of…R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine… | 08/24/2016Terminated |