BacT/ALERT¿ SN — Class II medical device recall Z-0749-2016
Terminated recall by bioMerieux, Inc., reported 2016-02-10. Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact
| Recall number | Z-0749-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2015-12-24 |
| Classified | 2016-02-03 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2017-12-04 |
| Countries outside the US | AE, AT, BG, CH, CZ, DE, ES, FR, GR, HU, IT, LB, LK, NL, PK, PL, RO, RS, RU, SA, SE, TR |
| Quantity | 2,741 units |
| Reason classes | specification failure |
| Lot numbers | 1042739 |
| Expiration dates | 2016-01-09 |
Product
BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
Reason for recall
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
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-0749-2016. 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.