# FDA recall Z-2331-2018

> **BioMerieux SA** · Class II · device recall initiated 2018-04-09.

## 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.

## Distribution

Distribution was made to the recalling firm's distribution center in KY.  There was no military/government distribution.

## Key facts

- **Recall number:** Z-2331-2018
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-09
- **Report date:** 2018-07-04
- **Termination date:** 2025-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marcy L'Etoile, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2018

## Citation

> AI Analytics. FDA recall Z-2331-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2331-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*