FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
- Recall number
- Z-0643-2007
- Recalling firm
- bioMerieux, Inc.
- Product
- BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
- Status
- Terminated
- Initiated
- 2007-01-11
- Posted
- 2007-03-22
- Terminated
- 2009-12-08
- Reason
- Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
- Root cause
- Other
- Action
- Consignees were notified by letter on/about 01/12/2007.
- Quantity
- 2136 cases (100 bottles per case)
- Distribution
- Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.
- Lot, serial or model codes
- Lot 1014768
- 510(k) numbers
- ["K020813"]
- PMA numbers
- not on file
- Product code
- MDB
- 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