BEUDAMED
    FDA Enforcement Class II Terminated

    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.

    Recall: Z-0697-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0697-2013
    Event ID
    63840
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    IDS (Immunodiagnostic Systems Ltd.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2013
    Initiation Date
    November 7, 2012
    Classification Date
    January 17, 2013
    Termination Date
    May 31, 2013
    Address
    Usworth Hall, N/A, Washington, N/A, N/A, United Kingdom

    Description

    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.

    Reason

    Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL.

    Code Info

    Lot # 17628

    Distribution

    US Nationwide Distribution

    Quantity

    675 units