BEUDAMED
    FDA Recall Terminated

    BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.

    Recall: Z-1159-2008 · Initiated November 13, 2007

    Recall

    Recall Number
    Z-1159-2008
    Event Number
    45875
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 13, 2007
    Posted
    June 11, 2008
    Terminated
    May 23, 2011
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.

    Reason

    False negative results due to reagent packs exhibiting low signal.

    Action

    On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.

    Distribution

    Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.

    Quantity

    8,804 kits