BacT/ALERT FA, bioMrieux, 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).
- Company
- Biomerieux, Inc.
- Recall Initiated
- December 24, 2015
- Terminated
- December 4, 2017
- Recall Number
- Z-0750-2016
- Quantity
- 2741 units in total
- Firm Location
- Durham, NC
Reason for Recall
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Distribution
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.
Lot / Code Info
Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
Root Cause
Packaging process control
Action Taken
Biomerieux sent a Product Recall Notice letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the referenced part and lot number and discard remaining inventory according to their facility's procedure for culture media. Customers were also instructed to contact their local bioMrieux representative for product replacement.