Home / Recalls / bioMerieux, Inc. / Z-1640-2022

Z-1640-2022 Class II Ongoing

Recalled by bioMerieux, Inc. — Durham, NC

FDA device recall Z-1640-2022 was initiated by bioMerieux, Inc. on Jul 13, 2022 and is designated Class II. Reason for recall: There are 7 reported software anomalies that may affect use of the device. The recall status is ongoing.

Recall Details

Product Type: Devices
Report Date: Sep 7, 2022
Initiation Date: Jul 13, 2022
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1640-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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Z-0814-2023 Class II — VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893 (Nov 9, 2022)
Z-0840-2023 Class II — GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 (Nov 9, 2022)