Device recall: VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of…

Class II FDA enforcement event 79620. Recall start date: 9 Apr 2018. Status in the FDA record: Terminated. Termination date: 2 Dec 2025.

Reason for recall, in the words of FDA

Invalid calibration with low calibrator S1 while using the product.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

BioMerieux SA started this device recall on 9 Apr 2018. The firm address in the FDA record is in Marcy L'Etoile. FDA put the recall in Class II. FDA event 79620 has 1 product record. The first FDA enforcement report date is 4 Jul 2018. The record gives the status Terminated, with the termination date 2 Dec 2025.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

BioMerieux SA, Marcy L'Etoile, France.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 79620: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2331-2018	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)…	59 units distributed to the U.S.	Class II	Terminated	4 Jul 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 21

Other events of the firm

Other FDA enforcement events of BioMerieux SA
Initiated	Product (first record)	Type	Class	Records
2 Sep 2021	MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System	Device	Class II	1
22 Jun 2021	MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results b	Device	Class II	1
17 Sep 2018	NucliSENS Magnetic Extraction Reagents	Device	Class II	1
23 Mar 2018	The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identi	Device	Class II	9
18 Oct 2017	NucliSENS Lysis Buffer Extended lot for RES 76675	Device	Class II	1
25 Apr 2017	ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the ant	Device	Class II	1
13 Apr 2017	ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptib	Device	Class II	2
17 Mar 2017	VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments o	Device	Class II	1
7 Mar 2017	NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid fr	Device	Class II	1
18 Jan 2017	ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the	Device	Class II	1

BioMerieux SA: all 21 events

Official channels

FDA enforcement report Z-2331-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 79620. https://recallregister.com/fda/ii/79620/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
What quantity of product is in FDA event 79620?: The FDA record gives this quantity: 59 units distributed to the U.S.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.