BEUDAMED
    FDA Recall Terminated

    VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.

    Recall: Z-2295-2010 · Initiated July 29, 2010

    Recall

    Recall Number
    Z-2295-2010
    Event Number
    56365
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 29, 2010
    Posted
    August 27, 2010
    Terminated
    November 2, 2010
    Address
    595 Anglum Rd, Hazelwood, MO, 63042

    Description

    VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.

    Reason

    Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results.

    Action

    BioMerieux issued an Urgent Product Removal Notice, dated July 29, 2010 to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and destroy any remaining inventory of the affected lot, and to notify their customers who received the product. All consignees were instructed to complete and return the Customer Acknowledgement and Product Replacement Form. These cards will be used to distribute replacement cards. Consignees can contact BioMerieux at 1-314- 731-8667.

    Distribution

    Worldwide Distribution: Country of Canada only. No product was distributed in the US.

    Quantity

    1297/ 20 card boxes