BEUDAMED
    FDA Recall Terminated

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.

    Recall: Z-1496-2018 · Initiated April 4, 2017

    Recall

    Recall Number
    Z-1496-2018
    Event Number
    79629
    Firm
    Diagnostic Hybrids, Inc.
    FEI Number
    1000122536
    Product Code
    DAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 4, 2017
    Terminated
    August 28, 2020
    Address
    2005 E State St, Ste 100, Athens, OH, 45701-2125

    Description

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.

    Reason

    There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.

    Action

    Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter.

    Distribution

    The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.

    Quantity

    101 kits