ETEST IMIPENEM RELEBACTAM — Class II medical device recall Z-2226-2021
Terminated recall by Biomerieux Inc, reported 2021-08-18, distributed nationwide. Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strain
| Recall number | Z-2226-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2021-06-24 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2025-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, GR, HR, IT, NL, PL, PT, SE |
| Quantity | 1,431 |
| Pathogens | pseudomonas |
| Lot numbers | 1007607290, 1007888860, 1007888870, 1008390030, 1008598340, 1008598350, 100859840, 1008701580, 1008701590 |
| Model numbers | 420925, 420927 |
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Reason for recall
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
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-2226-2021. 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.