BEUDAMED
    FDA Recall Terminated

    Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.

    Recall: Z-0131-06 · Initiated August 18, 2005

    Recall

    Recall Number
    Z-0131-06
    Event Number
    33199
    Firm
    Tosoh Bioscience, Inc.
    FEI Number
    1000123732
    Product Code
    JPK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 18, 2005
    Posted
    November 15, 2005
    Terminated
    August 25, 2006
    Address
    347 Oyster Point Blvd, Ste 201, South San Francisco, CA, 94080-1913

    Description

    Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.

    Reason

    The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.

    Action

    On August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.

    Distribution

    The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.

    Quantity

    3,284 boxes