Z-2331-2018Class II

VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the...

Name: Z-2331-2018 VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the...
Creator: BioMerieux SA
Published: 2018-04-09
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-04-09 / Terminated / root cause: manufacturing process

FDA source

BioMerieux SA began a recall of 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... on 2018-04-09. FDA classified it as Class II and gives the reason as "Invalid calibration with low calibrator S1 while using the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2331-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-09
Posted: 2018-06-29
Terminated: 2025-12-02
Recalling firm: bioMerieux, Inc.
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.
Product code: CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Reason for recall: Invalid calibration with low calibrator S1 while using the product.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.
Quantity in commerce: 59 units distributed to the U.S.
Distribution: Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Product codes and lots: Lot #1005888210 was distributed in the U.S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2331-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-28

Product code CGJ

K921746Class IVitek Immunodiagnostic Assay SystemBiomerieux Vitek, Inc. / cleared 1992-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)