Home / Recalls / Biomerieux Inc / Z-0865-2023

Z-0865-2023 Class II Ongoing

Recalled by Biomerieux Inc — Hazelwood, MO

Recall Details

Product Type
Devices
Report Date
January 11, 2023
Initiation Date
November 9, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

Reason for Recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Distribution Pattern

US Nationwide distribution.

Code Information

UDI/DI 03573026156930, Batch Numbers: 1009483380

Other recalls by Biomerieux Inc

  • Z-1236-2026 Class II — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o (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-0817-2023 Class II — ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 (November 9, 2022)
  • Z-0835-2023 Class II — VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 (November 9, 2022)
  • Z-0857-2023 Class II — VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 (November 9, 2022)
  • Z-0790-2023 Class II — VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 (November 9, 2022)
  • Z-0783-2023 Class II — API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 (November 9, 2022)
  • Z-0838-2023 Class II — VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438 (November 9, 2022)