R&D Systems, Inc.
R&D Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1978, most recent 2016, with 6 FDA device recalls on record.
Top product codes for R&D Systems, Inc.
FDA recalls by R&D Systems, Inc.
- 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;
- 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
- 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.
- 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.
- Z-0410-2019 — R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- Z-2887-2016 — R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by R&D Systems, Inc.
- K160606 — BC-5D Hematology Control
- K130962 — R&D 5D RETIC HEMATOLOGY CONTROL
- K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
- K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL
- K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
- K073178 — HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
- K072846 — CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
- K072268 — HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
- K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
- K070334 — R&D SICKLE QC CONTROL
- K061511 — R&D CBC-3D + CRP HEMATOLOGY CONTROL
- K061320 — R&D LH-NRBC HEMATOLOGY CONTROL
- K051339 — R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
- K042094 — R&D CBC-XE HEMATOLOGY CONTROL
- K034048 — R&D GLU-LINE HEMATOLOGY CONTROL
- K020229 — R & D BODY FLUID CONTROL
- K013898 — R&D RET-LINE KIT
- K010470 — R & D 4K RETIC
- K010461 — ADVIA RETIC PLUS
- K010409 — CBC-SF
- K003991 — CD-CAL PLUS CALIBRATOR
- K003874 — CBC-4K HEMATOLOGY CONTROL
- K003534 — PENTRA 5D
- K003208 — R & D 3K RETIC
- K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL
- K991876 — SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
- K983032 — CBC-5D HEMATOLOGY CONTROL
- K984099 — QBC CENTRIFUGAL HEMATOLOGY CONTROL
- K982231 — STATUSFLOW
- K972170 — ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
- K972172 — ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
- K964767 — QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
- K970718 — QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
- K970331 — CBC-4K HEMATOLOGY CONTROL
- K961673 — R&D RETIC-PG HEMATOLOGY CONTROL
- K961610 — R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
- K955925 — CBC-CAL PLUS HEMATOLOGY CALIBRATOR
- K954137 — QBC CENTRIFUGAL HEMATOLOGY CONTROL
- K943335 — RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
- K943336 — RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
- K942822 — CBC-LINE HEMATOLOGY LINEARITY CONTROL
- K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
- K931756 — QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
- K940089 — CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
- K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
- K931666 — QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
- K913879 — CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
- K912357 — 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
- K904637 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
- K904464 — CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
- K897060 — CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
- K893984 — HGB-CAL SET/MULTIPLE
- K893985 — HGB-CONTROL SET/MULTIPLE
- K891907 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
- K890749 — CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
- K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
- K881161 — TECH-CAL(TM)/MULTIPLE
- K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
- K873354 — QBC VENOUS BLOOD CONTROL/MULTIPLE
- K862858 — CBC-CAL (TM) PLUS/MULTIPLE
- K854823 — CBC-CAL/MULTIPLE
- K854353 — PLATELET-TROL II
- K852016 — LASER PLATELETCAL/MULTIPLE
- K850755 — CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
- K843962 — CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
- K843619 — RETIC-SET
- K842747 — HYCEL DILUTOR, VARIOUS MODELS/MULTI
- K842746 — HYCEL ROTOR-MIXER AND/OR MULTI
- K841848 — RETIC-SET
- K834585 — CELLTRAK-B
- K840302 — PLT - 4 PLATELET
- K832464 — MASSAGE TABLE AAT-100
- K831448 — SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
- K821318 — RETIC SET
- K802268 — CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
- K802265 — CBC PLT-4
- K802267 — PLT-4 SIZE-CHECK
- K802266 — HGB3 (1:251)
- K772195 — HEMATOLOGY REFERENCE CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.