Ceftriaxone TX 32 US S30 — Class II medical device recall Z-2126-2017
Terminated recall by BioMerieux SA, reported 2017-05-31, distributed nationwide. Potential performance issue on strain categorization.
| Recall number | Z-2126-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2017-01-01 |
| Classified | 2017-05-22 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2022-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 4,656 kits |
| Model numbers | 1002939460, 1002940890, 1003128150, 1003361690, 1003361950, 1003848910, 1003849820, 1004041770, 1004041790, 1004239890, 1004394530, 1004395510, 1004525370, 1004731200, 1004756050, 1004828430, 1004876830, 1004876860, 1004919030, 1005327130, 412302, 507058 |
Product
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
Reason for recall
Potential performance issue on strain categorization.
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-2126-2017. 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.