Home / Recalls / bioMerieux, Inc. / Z-0639-2019

Z-0639-2019 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
December 26, 2018
Initiation Date
November 13, 2018
Termination Date
July 7, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
five (5) VITEK¿ 2 Systems Software version 9.01

Product Description

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

Reason for Recall

The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.

Distribution Pattern

Nationwide distribution to CO, IL, MO, TX.

Code Information

Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260

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  • 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)