Recall Z-1602-2015 ยท LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
| Date | May 12, 2015 (initiated Mar 27, 2015) |
| Status | Terminated |
| Reason | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 |
| Root cause | Other |
| Action | The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488. |
| Quantity | 43,535/20-card cartons |
| Distribution | Distributed only to foreign subsidiaries and distributors, including Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.