BEUDAMED
    FDA Recall Terminated

    BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD

    Recall: Z-0256-2008 · Initiated September 25, 2007

    Recall

    Recall Number
    Z-0256-2008
    Event Number
    45332
    Firm
    Bio-Rad Labroatories Inc.
    FEI Number
    2915274
    Product Code
    LIP
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 25, 2007
    Posted
    November 9, 2007
    Terminated
    April 16, 2008
    Address
    4000 Alfred Noble Dr., Hercules, CA, 94547

    Description

    BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD

    Reason

    Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)

    Action

    The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date.

    Distribution

    Nationwide

    Quantity

    36