BEUDAMED
    FDA Recall Terminated

    R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

    Recall: Z-2887-2016 · Initiated August 24, 2016

    Recall

    Recall Number
    Z-2887-2016
    Event Number
    75016
    Firm
    R & D Systems, Inc.
    FEI Number
    2182501
    Product Code
    JNM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 24, 2016
    Posted
    September 26, 2016
    Terminated
    July 26, 2017
    Address
    614 McKinley Pl NE, Minneapolis, MN, 55413-2610

    Description

    R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

    Reason

    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.

    Action

    Consignees were sent via US mail on 8/24/2016 a R&D systems "Urgent Medical Device Recall" letter dated August 23, 2016. The letter described the problem and the product involved in the recall. Advised consignees to stop using the kits and to discard all unused kits and complete and return the enclosed Acknowledgement and Receipt Form. For questions contact Bio-Technes Technical Service Department at 1-612-379-2956 or [email protected].

    Distribution

    US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.

    Quantity

    725 kits (502 US, 223 OUS)