CLASS II ONGOING Device recall · Reported 5 Jan 2022 · FDA Enforcement Report

Vidas FSH recalled by bioMerieux

bioMerieux is recalling Vidas FSH, distributed nationwide in the US. The recall was initiated on 22 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 03573026156947, Lot #: 1008781470

Quantity recalledOne lot

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0434-2022
FDA event ID: 88797
Recalling firm: bioMerieux, Durham, NC
Classification: Class II
Status: Ongoing
Recall initiated: 22 Sep 2021
FDA classified: 28 Dec 2021
Reported: 5 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Sep 2021	Recall initiated by company
28 Dec 2021	Classified by FDA	+97 days
5 Jan 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

Product as listed by the FDA

VIDAS FSH, REF 30407-01

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Vidas FSH recalled?

Yes. bioMerieux recalled Vidas FSH on 22 Sep 2021. The recall is Class II and its status is Ongoing. Recall number Z-0434-2022.

Why was it recalled?

Which lots are affected?

UDI 03573026156947, Lot #: 1008781470

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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