BEUDAMED
    FDA Recall Terminated

    CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

    Recall: Z-0328-2016 · Initiated September 14, 2015

    Recall

    Recall Number
    Z-0328-2016
    Event Number
    72197
    Firm
    Biochemical Diagnostics Inc
    FEI Number
    2432495
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    September 14, 2015
    Posted
    November 23, 2015
    Terminated
    January 26, 2016
    Address
    180 Heartland Blvd, Edgewood, NY, 11717-8314

    Description

    CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

    Reason

    CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.

    Action

    Biochemical Diagnostics sent a Notice of Correction Letter (dated August 26, 2015) to customers via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return the verification form, per the notification. For questions contact Alere Technical Service at 866-216-0094 or by email at verifications.at [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    Domestic: 4,473 kits