Home / Recalls / BioMerieux SA / Z-0084-2022

Z-0084-2022 Class II Terminated

Recalled by BioMerieux SA — La Balme les Grottes, N/A

Recall Details

Product Type
Devices
Report Date
October 20, 2021
Initiation Date
September 2, 2021
Termination Date
March 9, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
542 units

Product Description

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

Reason for Recall

Under certain conditions, there is a risk for a false negative result.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.

Code Information

MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2

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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)