bioMerieux Kit — Class II medical device recall Z-0312-2013
Terminated recall by Biomerieux Inc, reported 2012-11-28, distributed in AR, AZ, CA, FL, KS, LA, MD, MN…. The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
| Recall number | Z-0312-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2012-10-16 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-10-28 |
| Distributed | AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA, WA |
| Countries outside the US | AE, AR, AT, BD, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EC, EG, ES, FR, GB, GR, GT, HK, HN, HR, IE, IL, IN, IT, JO, JP, KE, KR, KW, LT, LV, MT, MX, NL, NZ, PA, PE, PL, PT, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UY, VE, VN, ZA |
| Quantity | 205 kits |
| Reason classes | labeling, software |
| Model numbers | 411957 |
Product
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
Reason for recall
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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-0312-2013. 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.