BEUDAMED
    FDA Recall Terminated

    ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.

    Recall: Z-1596-2010 · Initiated December 30, 2009

    Recall

    Recall Number
    Z-1596-2010
    Event Number
    55165
    Firm
    Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila
    FEI Number
    2623532
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    December 30, 2009
    Posted
    May 19, 2010
    Terminated
    August 31, 2011
    Address
    Barceloneta, PR, 00617

    Description

    ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.

    Reason

    There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.

    Action

    Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.

    Distribution

    Nationwide Distribution -- Including Puerto Rico.

    Quantity

    1,326