FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
- Recall number
- Z-0243-2007
- Recalling firm
- bioMerieux, Inc.
- Product
- bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
- Status
- Terminated
- Initiated
- 2006-08-17
- Posted
- 2006-12-05
- Terminated
- 2009-12-08
- Reason
- Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
- Root cause
- Other
- Action
- Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock.
- Quantity
- 34,440
- Distribution
- Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.
- Lot, serial or model codes
- Lot number 1013177 (Product No. 259790)
- 510(k) numbers
- ["K021123"]
- 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