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R&D Systems, Inc.

United States US-MF-000024485 Last updated 17 Sep 2026

Devices
422
Registries
EUDAMEDFDA 510(k)GUDID
FDA recalls
7

Catalogue422

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FDA recalls7

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

R&D Systems, Inc. has seven FDA recall records initiated between April 15, 2004, and November 7, 2022, with statuses including open, classified, and terminated. The reasons cited involve packaging errors (e.g., incorrect control data cards, missing documentation), product defects (e.g., clotting in hematology controls, microbial contamination in controls), and discrepancies in labeling (e.g., incorrect reconstitution volumes, errors in CE marking instructions). Some records reference customer complaints about control results deviating from expected ranges, followed by internal investigations confirming inconsistencies.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2022

    • 7 Nov 2022 Z-0999-2023 Class III Terminated For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
    • 14 Jun 2022 Z-1390-2022 Class III Terminated 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

  • 2021

    • 20 Jan 2021 Z-1255-2021 Class II Terminated 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.

  • 2018

    • 1 Nov 2018 Z-0691-2019 Class III Terminated The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
    • 11 Sep 2018 Z-0410-2019 Class III Terminated 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.

  • 2016

    • 24 Aug 2016 Z-2887-2016 Class II Terminated 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.

  • 2004

    • 15 Apr 2004 Z-0992-04 Unclassified (pre-2012) Terminated 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.

What R&D Systems, Inc. makes

R&D Systems, Inc. manufactures hematology controls, including the SEDRite Plus Hematology Control, and body fluid analysis devices such as the Body Fluid-U. These products are designed for laboratory use in assessing blood and bodily fluid samples.

The company’s portfolio includes devices classified as Class B, Class I, Class II, and IVD General, with listings in the EUDAMED registry and FDA’s 510(k) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does R&D Systems, Inc. manufacture?

R&D Systems, Inc. specializes in hematology controls and body fluid analysis devices. Their products include the SEDRite Plus Hematology Control, which is used for quality control in laboratory testing, and the Body Fluid-U, designed for analyzing bodily fluids. These devices are intended for use in clinical or research settings to assess blood and other fluid samples.

Where is R&D Systems, Inc. based?

R&D Systems, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly when navigating regional requirements like those in the EU or the US.

Which regulatory registries list R&D Systems, Inc.’s devices?

R&D Systems, Inc.’s devices are listed in the EUDAMED registry, which tracks medical devices authorized in the European Union, and the FDA’s 510(k) database, which documents premarket notifications for devices seeking clearance in the US. These listings help ensure transparency and traceability for authorized products.

How are R&D Systems, Inc.’s devices classified under medical device regulations?

R&D Systems, Inc.’s devices fall into multiple classification categories: Class B, Class I, Class II, and IVD General. Classification determines regulatory requirements—e.g., risk level, labeling, and post-market surveillance—with IVD General covering in vitro diagnostics like hematology controls, while Class I/II/B reflect varying degrees of risk for other products.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States(from SRN)
Address
614, McKinley Place NE, Minneapolis, United States
PRRC contact
Mary Anne Williams
EUDAMED SRN
US-MF-000024485