BacT/ALERT SA Blood Culture Bottle — Class II medical device recall Z-0738-2013
Terminated recall by bioMerieux, Inc., reported 2013-02-06, distributed in AR, AZ, CA, CO, DE, FL, GA, IL…. BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
| Recall number | Z-0738-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2012-12-25 |
| Classified | 2013-01-25 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2014-06-03 |
| Distributed | 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, WV |
| Countries outside the US | CN, CW, JP |
| Quantity | 1,690 cases |
| Lot numbers | 1031866 |
| Model numbers | 259789 |
Product
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.
Reason for recall
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0738-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.