—#115293

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.

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K020931
Affected lot / code info: Catalog Number: 259789, Lots/Batch: 1031866

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" and Acknowledgement Form on January 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local bioMerieux Customer Service Representative for additional assistance.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

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.

Timeline

Recall initiated: 2012-12-25
Posted by FDA: 2013-01-25
Terminated: 2014-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115293. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.