Recall Z-0749-2016 ยท MDB System, Blood Culturing
bioMerieux, Inc.
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).
| Date | Dec 24, 2015 |
| Status | Terminated |
| Reason | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. |
| Root cause | Packaging process control |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993421 | BACT/ALERT SN Organon Teknika Corp., Dec 14, 1999 |