Exact FDA event identifier

Event 79620

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: April 09, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: BioMerieux SA

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2331-2018

Recall number: Z-2331-2018
Initiated: April 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: 59 units distributed to the U.S.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Invalid calibration with low calibrator S1 while using the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Invalid calibration with low calibrator S1 while using the product.

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.