BioMerieux SA: Medical Device Recall in 2018 - (Recall #: Z-2331-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 9, 2018

Date Posted: July 4, 2018

Recall Number: Z-2331-2018

Event ID: 79620

Reason for Recall:

Invalid calibration with low calibrator S1 while using the product.

Status: Terminated

Product Quantity: 59 units distributed to the U.S.

Code Information:

Lot #1005888210 was distributed in the U.S.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated