Device product
BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
Z-0750-2016
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 73027
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2741 units in total
- Official record key
device-enforcement:Z-0750-2016
Official wording
Reason: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Code information: Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
Distribution pattern: Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.
Derived failure modes
-
Unknown
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.