Recalls / —
—#135323
Product
Vitek 2 AST-YS01 REF 22 108, 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.
- FDA product code
- LTW — Susceptibility Test Cards, Antimicrobial
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.
Why it was recalled
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Root cause (FDA determination)
Other
Action the firm took
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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Timeline
- Recall initiated
- 2015-03-27
- Posted by FDA
- 2015-05-12
- Terminated
- 2017-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #135323. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.