Device recall: VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions…

Class II FDA enforcement event 90605. Recall start date: 13 Jul 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

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, Inc. started this device recall on 13 Jul 2022. The firm address in the FDA record is in Durham, NC. FDA put the recall in Class II. FDA event 90605 has 1 product record. The first FDA enforcement report date is 7 Sep 2022. The record gives the status Ongoing.

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.

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

Recalling firm

bioMerieux, Inc., Durham, NC.

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 90605: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1640-2022	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		Class II	Ongoing	7 Sep 2022

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 2022: 839
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 57

Other events of the firm

Other FDA enforcement events of bioMerieux, Inc.
Initiated	Product (first record)	Type	Class	Records
4 Jun 2026	VITEK 2 AST-N447 TEST KIT Product reference 424620	Device	Class II	1
5 Jan 2026	VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem	Device	Class II	1
26 Jun 2025	VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consis	Device	Class II	1
14 Mar 2024	VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) A	Device	Class I	1
6 Feb 2023	MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments f	Device	Class II	1
9 Nov 2022	API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300	Device	Class II	94
20 Jul 2022	NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.	Device	Class II	1
29 Mar 2022	VITEK 2 Systems and VITEK 2 with MYLA.	Device	Class II	1
9 Feb 2022	VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.	Device	Class II	1
20 Dec 2021	API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identificatio	Device	Class II	1

bioMerieux, Inc.: all 57 events

Official channels

FDA enforcement report Z-1640-2022The 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 90605. https://recallregister.com/fda/ii/90605/. 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: International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.
How many FDA recalls does bioMerieux, Inc. have?: bioMerieux, Inc. is the recalling firm in 57 enforcement events on this register. This event is 1 of them.