Home / Recalls / bioMerieux, Inc. / Z-3179-2018

Z-3179-2018 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
August 13, 2018
Termination Date
November 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2538 cartons

Product Description

VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Reason for Recall

Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).

Distribution Pattern

Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,

Code Information

Lot Numbers: 7400410103, 7400697403

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)