VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Reported: December 26, 2018 Initiated: November 13, 2018 #Z-0639-2019
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.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- five (5) VITEK¿ 2 Systems Software version 9.01
- Distribution
- Nationwide distribution to CO, IL, MO, TX.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
VITEK¿ 2 Systems Software Version 9.01 Update Kit.. Recalled by bioMerieux, Inc.. Units affected: five (5) VITEK¿ 2 Systems Software version 9.01.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0639-2019.
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