BacT/ALERT SA Blood Culture Bottle recallZ-0738-2013 · bioMerieux, Inc. · initiated Dec 25, 2012
Class II Terminated All recalls posted in January 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from bioMerieux, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0738-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 25, 2012
- Posted by the FDA
- Jan 25, 2013
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 1690 cases
- Product code
- MDB
- FDA submissions
- K020931
- Distribution
- 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 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.
Code information (models, lots, serial numbers)
Catalog Number: 259789, Lots/Batch: 1031866
Other devices under the same FDA submission
1 device cleared under K020931 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BACT/ALERT® SABiomerieux , Inc. · System, blood culturing22 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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