VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches
FDA device recall Z-2295-2010 · posted 2010-08-27 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 1297/ 20 card boxes
- Distribution
- Worldwide Distribution: Country of Canada only. No product was distributed in the US.
- Date initiated
- 2010-07-29
- Date posted
- 2010-08-27
- Date terminated
- 2010-11-02
- Location
- Hazelwood, MO
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