Recall Z-2295-2010 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
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.
| Date | Aug 27, 2010 (initiated Jul 29, 2010) |
| Status | Terminated |
| Reason | Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results. |
| Root cause | Packaging |
| 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. |
| Quantity | 1297/ 20 card boxes |
| Distribution | Worldwide Distribution: Country of Canada only. No product was distributed in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.