Z-1640-2022Class II

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

Name: 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...
Creator: bioMerieux, Inc.
Published: 2022-07-13
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2022-07-13 / Open, Classified / root cause: software

FDA source

bioMerieux, Inc. began a recall of 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 on 2022-07-13. FDA classified it as Class II and gives the reason as "There are 7 reported software anomalies that may affect use of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1640-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-13
Posted: 2022-08-26
Recalling firm: bioMerieux, Inc.
Product: 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
Product code: NSX
Reason for recall: There are 7 reported software anomalies that may affect use of the device.
Root cause tag: software
FDA root cause: Software design
Action: Recall notification was issued on or around July 13, 2022. Subsidiaries/distributors are instructed to identify/notify any impacted customer(s) in their region(s) of responsibility. Each customer is requested to return an Acknowledgement Form indicating that they are in receipt of the letter and will comply with the required actions (as appropriate to their laboratory).
Distribution: International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1640-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1640-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26

Product code NSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)