BEUDAMED
    FDA Enforcement Class II 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 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1496-2018
    Event ID
    79629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostic Hybrids, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    April 4, 2017
    Classification Date
    April 24, 2018
    Termination Date
    August 28, 2020
    Address
    2005 E State St Ste 100, N/A, Athens, OH, 45701-2125, United States

    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.

    Code Info

    Lot 084007

    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