VIDAS FSH — Class II medical device recall Z-2331-2018
Terminated recall by BioMerieux SA, reported 2018-07-04, distributed in KY. Invalid calibration with low calibrator S1 while using the product.
| Recall number | Z-2331-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2018-04-09 |
| Classified | 2018-06-28 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2025-12-02 |
| Distributed | KY |
| Quantity | 59 units |
| Lot numbers | 1005888210 |
| Model numbers | 30407-01 |
Product
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.
Reason for recall
Invalid calibration with low calibrator S1 while using the product.
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-2331-2018. 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.