Z-0243-2007
bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
bioMerieux, Inc. / initiated 2006-08-17 / Terminated / root cause: manufacturing process
bioMerieux, Inc. began a recall of bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0243-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- bioMerieux, Inc.
- Product
- bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
- Product code
- MDB System, Blood Culturing
- 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.
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- 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.
- Product codes and lots
- Lot number 1013177 (Product No. 259790)
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