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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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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
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.

Product Detail

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