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Recall Observatory FDA recall evidence

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

December 25, 2012

Class II

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

    reason.no_named_rule · v1.0.0

    BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.