Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US — Class I medical device recall Z-0440-2016
Terminated recall by Biomerieux, reported 2015-12-30, distributed nationwide. Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptib
| Recall number | Z-0440-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux, Letoile, N/A, France |
| Recall initiated | 2015-11-19 |
| Classified | 2015-12-23 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CH, CL, CO, CZ, DE, EE, ES, FR, GB, HU, IL, IN, IT, JP, KE, KW, LB, LT, MY, NL, OM, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, TN, TR, UY, VE, VN, ZA |
| Quantity | 1,216 units |
| Lot numbers | 1001938220, 1002372580, 1003069250, 1003558430, 1003903640, 1004394540 |
| Model numbers | 412433 |
Product
Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Reason for recall
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
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-0440-2016. 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.