bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
This recall has been terminated (originally issued December 5, 2006).
- Company
- Biomerieux, Inc.
- Recall Initiated
- August 17, 2006
- Posted
- December 5, 2006
- Terminated
- December 8, 2009
- Recall Number
- Z-0243-2007
- Quantity
- 34,440
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
Lot number 1013177 (Product No. 259790)
Root Cause
Other
Action Taken
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.
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