BEUDAMED
    FDA Recall Terminated

    IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.

    Recall: Z-1069-2007 · Initiated April 10, 2007

    Recall

    Recall Number
    Z-1069-2007
    Event Number
    37920
    Firm
    Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
    FEI Number
    2623532
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 10, 2007
    Posted
    July 12, 2007
    Terminated
    February 14, 2012
    Address
    Barceloneta, PR, 00617-3009

    Description

    IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.

    Reason

    An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.

    Action

    The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots.

    Distribution

    Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS.

    Quantity

    3176 kits