CLASS II ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report

Vitek 2 / Myla Vitek recalled by bioMerieux

bioMerieux is recalling Vitek 2 / Myla Vitek 2. The recall was initiated on 13 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568

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-1640-2022
FDA event ID: 90605
Recalling firm: bioMerieux, Durham, NC
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jul 2022
FDA classified: 26 Aug 2022
Reported: 7 Sep 2022
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Medical Software

Timeline

13 Jul 2022	Recall initiated by company
26 Aug 2022	Classified by FDA	+44 days
7 Sep 2022	Published in enforcement report	+12 days

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

Reason for recall

There are 7 reported software anomalies that may affect use of the device.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

Where it was distributed

International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.

Questions about this recall

Why was it recalled?

There are 7 reported software anomalies that may affect use of the device.

Which lots are affected?

VITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568

Where was it sold?

International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.

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 26 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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Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide

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