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Terminated

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 Recall Z-0738-2013 · Posted 2013-01-25

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeMDB
Date Initiated2012-12-25
Date Terminated2014-06-03
Product Quantity1690 cases

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020931BACT/ALERT SA CULTURE BOTTLEbioMerieux, Inc. · 2002-04-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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