FDA Medical Device Recalls (openFDA)
Biomerieux Inc: Vitek 2 AST-YS06 REF 412 610, 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.
- Recall number
- Z-1601-2015
- Recalling firm
- Biomerieux Inc
- Product
- Vitek 2 AST-YS06 REF 412 610, 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.
- Status
- Terminated
- Initiated
- 2015-03-27
- Posted
- 2015-05-12
- Terminated
- 2017-03-24
- 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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.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
- 1,025/20-card cartons
- Distribution
- Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
- Lot, serial or model codes
- lot 286303720, expiration 08-APR-15
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LTW
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28