Minneapolis, MN, United States
R & D Systems, Inc. recalls
5 recalls recorded since 2018, most recently on 7 November 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 7 November 2022
- Terminated
- 26 May 2026
- Reason
- For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IA, KY, LA, MA, MO, NC, NJ, NY, OH, TX and Puerto Rico. The countries of Brazil, China, Costa Rica, Czech Republic, France, Germany, Great Britain, Honduras, Hungary, Indonesia, Israel, Japan, Kuwait, Mexico, Netherland
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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;
Terminated Class III Medical devices
- Recall started
- 14 June 2022
- Terminated
- 24 July 2026
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, MN, UT, OH, MA, TX, PR, PA, NJ, CA, WI, LA, Puerto Rico, and the countries of CANADA, UNITED KINGDOM, ISRAEL, MEXICO, THAILAND, CHINA, HONG KONG, AUSTRALIA, INDONESIA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 20 January 2021
- Terminated
- 13 February 2023
- Reason
- 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.
- Distribution
- USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 (sTf
Terminated Class III Medical devices
- Recall started
- 1 November 2018
- Terminated
- 3 November 2020
- Reason
- The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
- Distribution
- US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 ai
Terminated Class III Medical devices
- Recall started
- 11 September 2018
- Terminated
- 1 September 2020
- Reason
- 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.
- Distribution
- IA and CO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0410-2019
- R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.