Home / Recalls / Biomerieux Inc / Z-0849-2023

Z-0849-2023 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
2 units

Product Description

ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927

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 03573026551544, Batch Numbers: 1008988170

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)