Home / Recalls / Biomerieux Inc / Z-0829-2023

Z-0829-2023 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 RIFAMPICIN RI 32 US S30, CATALOG 412449

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 03573026378592, Batch Numbers: 1009190620

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-0837-2023 Class II — VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 (November 9, 2022)
  • Z-0810-2023 Class II — API JAMES 2AMP, CATALOG 70542 (November 9, 2022)
  • Z-0815-2023 Class II — VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071 (November 9, 2022)
  • Z-0861-2023 Class II — VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 (November 9, 2022)
  • Z-0852-2023 Class II — ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 (November 9, 2022)
  • Z-0809-2023 Class II — API NIT1 NIT2 REAGENTS, CATALOG 70442 (November 9, 2022)