ETEST ETP32 — Class II medical device recall Z-2095-2017
Terminated recall by BioMerieux SA, reported 2017-05-24, distributed nationwide. False susceptible results
| Recall number | Z-2095-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2017-04-25 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2022-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,238 units |
| Lot numbers | 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004113370, 1004142070, 1004325260, 1004382730, 1004482780, 1004785720, 1004890160, 1005134380, 1005134390, 1005357180, 1005442470 |
| Model numbers | 531600, 531640 |
Product
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
Reason for recall
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-2095-2017. 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.