Data / Medical devices / United States / R & D Systems, Inc.
R & D Systems, Inc.: FDA-registered device maker in Minneapolis, MN, United States, 35 510(k) clearances
R & D Systems, Inc. is registered with the FDA (registration 2182501) in Minneapolis, MN, United States. It lists 10 device types. The FDA files 35 510(k) clearances under its listings, the newest dated September 1, 2016. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2182501
- Address
- 614 Mckinley Pl Ne, Minneapolis, MN, United States, 55413
- Owner or operator
- R & D SYSTEMS, INC. (2182501)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2026
- Brand names listed
- 3K Retic Hematology Control, 4K Retic Hematology Control, BC-5D Hematology Controls, Bio Rad Liquicheck Hematology Control (X), Body Fluid Control, Body Fluid-I Control, CBC-3D, CBC-3D for Mindray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Erythropoietin | GGT | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator For Cell Indices | KRX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator For Platelet Counting | KRY | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator For Red-Cell And White-Cell Counting | KSA | 2 | Manufacturer | accessdata.fda.gov |
| Control, Cell Counter, Normal And Abnormal | JCN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Control, Hemoglobin | GGM | 2 | Manufacturer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2016 | K160606 | BC-5D Hematology Control | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| April 28, 2011 | K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| January 29, 2010 | K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| October 28, 2009 | K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| December 27, 2007 | K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| November 20, 2007 | K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| March 29, 2007 | K070334 | R&D SICKLE QC CONTROL | GGM | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| July 10, 2006 | K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| September 1, 2004 | K042094 | R&D CBC-XE HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| February 6, 2002 | K020229 | R & D BODY FLUID CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| January 22, 2002 | K013898 | R&D RET-LINE KIT | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| May 11, 2001 | K010470 | R & D 4K RETIC | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| April 3, 2001 | K010461 | ADVIA RETIC PLUS | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| March 16, 2001 | K010409 | CBC-SF | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| January 16, 2001 | K003991 | CD-CAL PLUS CALIBRATOR | KRX | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| January 12, 2001 | K003874 | CBC-4K HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| December 1, 2000 | K003534 | PENTRA 5D | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| November 7, 2000 | K003208 | R & D 3K RETIC | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| September 11, 2000 | K002511 | FETALTROL | JPK | Substantially Equivalent | Trillium Diagnostics, LLC | accessdata.fda.gov |
| November 12, 1999 | K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | GGM | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| June 17, 1999 | K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| February 17, 1999 | K983032 | CBC-5D HEMATOLOGY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| July 20, 1998 | K982231 | STATUSFLOW | GKZ | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| July 1, 1996 | K961610 | R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) | GKZ | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| February 29, 1996 | K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | KRX | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| December 12, 1994 | K943336 | RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| October 7, 1994 | K942822 | CBC-LINE HEMATOLOGY LINEARITY CONTROL | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| July 19, 1994 | K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | GGT | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| April 21, 1994 | K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | GGT | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| November 27, 1991 | K913879 | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| February 27, 1989 | K890749 | CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| May 2, 1988 | K881161 | TECH-CAL(TM)/MULTIPLE | KSA | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| November 1, 1984 | K843962 | CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| March 12, 1984 | K840302 | PLT - 4 PLATELET | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| November 12, 1980 | K802265 | CBC PLT-4 | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 7, 2022 | 91136 | Class III | Terminated | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. | accessdata.fda.gov |
| June 14, 2022 | 90445 | Class III | Terminated | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095 | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-2797) for product inserts 750095.28 and 750095.29. The erroneous label CE2797 were | accessdata.fda.gov |
| January 20, 2021 | 87223 | Class II | Terminated | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR | R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits. | accessdata.fda.gov |
| November 1, 2018 | 81550 | Class III | Terminated | Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in t | The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4. | accessdata.fda.gov |
| September 11, 2018 | 81121 | Class III | Terminated | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL. | accessdata.fda.gov |
| August 24, 2016 | 75016 | Class II | Terminated | R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1. | R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine IVD Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high. | accessdata.fda.gov |
| April 15, 2004 | 29044 | Not yet classified | Terminated | ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horib | Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator For Red-Cell And White-Cell Counting
- All makers of Calibrator For Cell Indices
- All makers of Calibrator For Platelet Counting
- All makers of Calibrator For Hemoglobin And Hematocrit Measurement
- All makers of Counter, Differential Cell
- All makers of Mixture, Hematology Quality Control
Updated January 19, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.