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 | |
| 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. |
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