R & D Systems Recalls
6 recalls on record · October 5, 2016 to January 25, 2023 · Medical Devices
Recalls by year
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21
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 25, 2023Medical DevicesFDA
R & D Systems, Inc. recalls R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;
Hazard: For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
July 27, 2022Medical DevicesFDA
R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoie
Hazard: 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
March 24, 2021Medical DevicesFDA
R & D Systems, Inc. recalls Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked
Hazard: 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.
January 9, 2019Medical DevicesFDA
R & D Systems, Inc. recalls Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunos
Hazard: The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
November 14, 2018Medical DevicesFDA
R & D Systems, Inc. recalls R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Hazard: 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.
October 5, 2016Medical DevicesFDA
R & D Systems, Inc. recalls R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (s
Hazard: 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.