BEUDAMED
    FDA Recall Terminated

    Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.

    Recall: Z-0265-05 · Initiated November 8, 2004

    Recall

    Recall Number
    Z-0265-05
    Event Number
    30421
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CGN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 8, 2004
    Posted
    November 30, 2004
    Terminated
    August 13, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.

    Reason

    A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.

    Action

    Product Corrective Action (PCA) letter that informs customers (who ordered Access Chlamydia reagent in the past 24 months and have an Access 2 Immunoassay System) of this potential issue sent via US mail on November 8, 2004. The letter instructs customers to use unique Sample IDs for all samples assayed on the system - including those which have been manipulated offline prior to assay. A Technical Information Update will be issued to inform all support personnel of this issue.

    Distribution

    Nationwide and Canada

    Quantity

    1,197