Device product
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Z-0738-2013
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 64054
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1690 cases
- Official record key
device-enforcement:Z-0738-2013
Official wording
Reason: BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Code information: Catalog Number: 259789, Lots/Batch: 1031866
Distribution pattern: Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
Derived failure modes
-
Unknown
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.