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.
FDA Recall Z-2295-2010 · Posted 2010-08-27
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Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLON
Date Initiated2010-07-29
Date Terminated2010-11-02
Product Quantity1297/ 20 card boxes
Reason for Recall
Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution: Country of Canada only. No product was distributed in the US.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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