bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF… recallZ-0243-2007 · bioMerieux, Inc. · initiated Aug 17, 2006
Terminated All recalls posted in December 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from bioMerieux, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0243-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 17, 2006
- Posted by the FDA
- Dec 5, 2006
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 34,440
- Product code
- MDB
- FDA submissions
- K021123
- 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.
Product description
bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
Code information (models, lots, serial numbers)
Lot number 1013177 (Product No. 259790)
Other devices under the same FDA submission
1 device cleared under K021123 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BACT/ALERT® SNBiomerieux , Inc. · System, blood culturing33 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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