FDA Medical Device Recalls (openFDA)
Biomerieux Inc: bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
- Recall number
- Z-1013-2013
- Recalling firm
- Biomerieux Inc
- Product
- bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
- Status
- Terminated
- Initiated
- 2013-02-06
- Posted
- 2013-03-27
- Terminated
- 2013-10-30
- Reason
- The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
- Root cause
- Error in labeling
- Action
- bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.
- Quantity
- 4/20-card cartons
- Distribution
- Distributed only in HI.
- Lot, serial or model codes
- lot number: 540274420
- 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