FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: BacT/ALERT FN Culture Bottles, Product Number 259793
- Recall number
- Z-1189-2007
- Recalling firm
- bioMerieux, Inc.
- Product
- BacT/ALERT FN Culture Bottles, Product Number 259793
- Status
- Terminated
- Initiated
- 2007-02-16
- Posted
- 2007-08-22
- Terminated
- 2009-12-08
- Reason
- Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.
- Root cause
- Other
- Action
- Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.
- Quantity
- 2,403 cases (100 bottles per case)
- Distribution
- Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom
- Lot, serial or model codes
- Product number 259743, Lot 1015145
- 510(k) numbers
- ["K992432"]
- PMA numbers
- not on file
- Product code
- MBD
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- 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