BEUDAMED
    FDA Recall Terminated

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    Recall: Z-0263-05 · Initiated October 29, 2004

    Recall

    Recall Number
    Z-0263-05
    Event Number
    30394
    Firm
    DPC Cirrus
    FEI Number
    1000122204
    Product Code
    DHA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2004
    Posted
    November 30, 2004
    Terminated
    January 18, 2005
    Address
    62 Flanders Bartley Rd, Flanders, NJ, 07836-4715

    Description

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    Reason

    Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.

    Action

    The firm faxed the technical bulletin notification to each domestic customer on 10/22/2004. International customers were e-mailed and faxed on the same day.

    Distribution

    The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy.

    Quantity

    17 UNITS