R & D Systems, Inc.
Minneapolis, MN, US
R & D SYSTEMS, INC. appears in FDA device records in Minneapolis, MN. FDA records list 79 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 79FDA records hold 79 510(k) clearances for R & D Systems, Inc. between 1978 and 2016. The busiest year on record is 1984, with 7. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 4 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 7 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 2 |
| 1993 | 2 |
| 1994 | 6 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 5 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 5 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160606 | BC-5D Hematology Control | JPK | Substantially Equivalent | |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | JPK | Substantially Equivalent | |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | JPK | Substantially Equivalent | |
| K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 | JPK | Substantially Equivalent | |
| K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S | JPK | Substantially Equivalent | |
| K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 | JPK | Substantially Equivalent | |
| K070334 | R&D SICKLE QC CONTROL | GGM | Substantially Equivalent | |
| K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K061320 | R&D LH-NRBC HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K051339 | R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K042094 | R&D CBC-XE HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K034048 | R&D GLU-LINE HEMATOLOGY CONTROL | JJX | Substantially Equivalent | |
| K020229 | R & D BODY FLUID CONTROL | JPK | Substantially Equivalent | |
| K013898 | R&D RET-LINE KIT | JPK | Substantially Equivalent | |
| K010470 | R & D 4K RETIC | JPK | Substantially Equivalent | |
| K010461 | ADVIA RETIC PLUS | JPK | Substantially Equivalent | |
| K010409 | CBC-SF | JPK | Substantially Equivalent | |
| K003991 | CD-CAL PLUS CALIBRATOR | KRX | Substantially Equivalent | |
| K003874 | CBC-4K HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K003534 | PENTRA 5D | JPK | Substantially Equivalent | |
| K003208 | R & D 3K RETIC | JPK | Substantially Equivalent | |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | GGM | Substantially Equivalent | |
| K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE | JPK | Substantially Equivalent | |
| K983032 | CBC-5D HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K984099 | QBC CENTRIFUGAL HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K982231 | STATUSFLOW | GKZ | Substantially Equivalent | |
| K972172 | ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION | JPK | Substantially Equivalent | |
| K972170 | ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION | JPK | Substantially Equivalent | |
| K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | JZG | Substantially Equivalent | |
| K970718 | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | JNM | Substantially Equivalent | |
| K970331 | CBC-4K HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K961673 | R&D RETIC-PG HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K961610 | R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) | GKZ | Substantially Equivalent | |
| K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR | KRX | Substantially Equivalent | |
| K954137 | QBC CENTRIFUGAL HEMATOLOGY CONTROL | JPK | Substantially Equivalent | |
| K943336 | RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | |
| K943335 | RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | |
| K942822 | CBC-LINE HEMATOLOGY LINEARITY CONTROL | JPK | Substantially Equivalent | |
| K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | GGT | Substantially Equivalent | |
| K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | GGT | Substantially Equivalent | |
| K940089 | CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | JCN | Substantially Equivalent | |
| K931666 | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY | GGT | Substantially Equivalent | |
| K913879 | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | |
| K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | KRX | Substantially Equivalent | |
| K904637 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE | JPK | Substantially Equivalent | |
| K904464 | CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED | JPK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2182501 | 2182501 | R & D SYSTEMS, INC. | 614 Mckinley Pl Ne, MINNEAPOLIS, MN 55413 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GKHApparatus, Automated Blood Cell Diluting
- GGTAssay, Erythropoietin
- KJNBrilliant Cresyl Blue
- KRXCalibrator For Cell Indices
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- KRYCalibrator For Platelet Counting
- KSACalibrator For Red-Cell And White-Cell Counting
- JCNControl, Cell Counter, Normal And Abnormal
- GGMControl, Hemoglobin
- GKZCounter, Differential Cell
- KSQDevice, Blood Mixing And Blood Weighing
- LIBDevice, General Purpose, Microbiology, Diagnostic
- FRZDevice, Patient Transfer, Powered
- GIFDiluent, Blood Cell
- JNMImmunochemical, Transferrin
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KQCStains, Hematology
- GKRSystem, Hemoglobin, Automated
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- JFBTable, Physical Therapy, Multi Function
- KHGWhole Blood Hemoglobin Determination
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0999-2023 | 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-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H; (6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H; (7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H; (8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H; (9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H. Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes. OEM/Own-label distributor labels: (1) Alere 380 Hemo Control (L-N-H), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; control lot #B1122N, no UDI (2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N (3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N (4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N. (5) Elite 3 HEM Control Normal, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N; (6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10 (7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3; kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N. (8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D; and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D. (9) mindray BC-3D, P/N 040-001423-00. (10) MINDRAY BC-3D CONTROL, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; kit lot #B1122, control lot #B1122N. (11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N. (12) Nihon Kohden MEK-3D Hematology Control, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN. (13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN. (14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H. (15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N. (17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N; | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. | Class III | Terminated | |
| Z-1390-2022 | 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 in the IFU insert revision 750095.28 for the 408 affected lots that were shipped. No product was packed with erroneous insert revision 750095.29. Since the product is currently CE marked as a Class I - self-certified product under the EU In Vitro Diagnostics Directive, the Notified Body designation should not be specified. As part of the corrective action, the firm has notified the customers who received the products with erroneous labeling, and is conducting the replacements with the correct product insert containing the Insert Revision 750095.30 | Class III | Completed | |
| Z-1255-2021 | 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) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia. | 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. | Class II | Terminated | |
| Z-0691-2019 | 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 the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease. | The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4. | Class III | Terminated | |
| Z-0410-2019 | 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. | Class III | Terminated | |
| Z-2887-2016 | 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. | Class II | Terminated | |
| Z-0992-04 | 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 Horiba Ltd., Kyoto, Japan | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain