Z-0639-2019 Class II Terminated
FDA device recall Z-0639-2019 was initiated by bioMerieux, Inc. on Nov 13, 2018 and is designated Class II. 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 recall status is terminated (terminated Jul 7, 2021). Affected quantity: five (5) VITEK¿ 2 Systems Software version 9.01.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Nov 13, 2018
- Termination Date
- Jul 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0639-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026