The Recall Desk

Manufacturer

R & D Systems, Inc.

6 recalls in our database name R & D Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2023-01-25

Of the 6 recalls from R & D Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Devices)·Z-0999-2023·2023-01-25

    R&D CBC-3D Hematology Control Recalled for Potential Microbial Contamination

    R&D Systems is recalling one lot of CBC-3D Hematology Control due to potential microbial contamination that may cause hemolysis or deterioration in the Normal control level.

    Product
    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,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1390-2022·2022-07-27

    Erythropoietin Control Product Instructions Contain Incorrect CE Marking

    R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2021·2021-03-24

    R&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits

    R&D Systems is recalling 156 Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls.

    Product
    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
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0691-2019·2019-01-09

    R&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card

    R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0410-2019·2018-11-14

    R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error

    R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.

    Product
    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2887-2016·2016-10-05

    R&D Systems Recalls Quantikine IVD sTfR Immunoassay Kits Due to Control Issues

    R&D Systems is recalling 725 Quantikine IVD sTfR Immunoassay Kits because internal testing confirmed that control results were out of range high.

    Product
    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.
    Category
    Medical Device
    Distribution
    12 states