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

Z-1640-2022 Class II Ongoing

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
September 7, 2022
Initiation Date
July 13, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

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

Other recalls by bioMerieux, Inc.

  • Z-1236-2026 Class II — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ce (January 5, 2026)
  • Z-2671-2025 Class II — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs0 (June 26, 2025)
  • Z-1464-2024 Class I — VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial suscep (March 14, 2024)
  • Z-1201-2023 Class II — MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connec (February 6, 2023)
  • Z-0856-2023 Class II — VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 (November 9, 2022)
  • Z-0791-2023 Class II — VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346 (November 9, 2022)
  • Z-0832-2023 Class II — BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 (November 9, 2022)
  • Z-0824-2023 Class II — ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 (November 9, 2022)
  • Z-0852-2023 Class II — ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 (November 9, 2022)
  • Z-0871-2023 Class II — PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR (November 9, 2022)