Recalls / —
—#142817
Product
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).
- FDA product code
- MDB — System, Blood Culturing
- Device class
- Class 1
- Medical specialty
- Microbiology
- 510(k) numbers
- K020813
- Affected lot / code info
- Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.
Why it was recalled
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Root cause (FDA determination)
Packaging process control
Action the firm took
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.
Recalling firm
- Firm
- bioMerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- 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.
Timeline
- Recall initiated
- 2015-12-24
- Terminated
- 2017-12-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.