Recall Z-0749-2016
bioMerieux, Inc. · initiated December 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BacT/ALERT SN, 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).
Codes / lots: Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.
Reason for recall
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
FDA-determined 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.
Details
- Recall number
- Z-0749-2016
- Initiated
- December 24, 2015
- Terminated
- December 4, 2017
- Product code
- MDB – System, Blood Culturing
- Quantity
- 2741 units in total
- 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.
- Recalling firm
- bioMerieux, Inc., Durham, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0750-2016 Class II | BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with…Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and… | 12/24/2015Terminated |