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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0738-2013
Classification Class II
Code Info Catalog Number: 259789, Lots/Batch: 1031866
Product Distributed Qty 1690 cases
Reason For Recall BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.

Event Detail

Event Id 64054
Product Type Devices
Status Ongoing
Recalling Firm bioMerieux, Inc.
City Durham
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-25
Initial Firm Notification of Consignee or Public E-Mail
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.