Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Sys
FDA device recall Z-1603-2015 · posted 2015-05-12 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
- Action taken
- 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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
- Root cause
- Other
- Status
- Terminated
- Product code
- LTW
- Quantity affected
- 1604/20-card cartons
- Distribution
- Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
- Date initiated
- 2015-03-27
- Date posted
- 2015-05-12
- Date terminated
- 2017-03-24
- Location
- Hazelwood, MO
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