FDA Device recall Z-0639-2019
VITEK¿ 2 Systems Software Version 9.01 Update Kit
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of VITEK¿ 2 Systems Software Version 9.01 Update Kit by Biomerieux, citing the VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0639-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-13 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Reason
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.
Identifiers
| code_info | Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Biomerieux
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
FDA Device · Class II · 2026-09-30 · Biomerieux - VITEK 2 AST-N447 TEST KIT Product reference 424620
FDA Device · Class II · 2026-07-15 · Biomerieux - VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01…
FDA Device · Class II · 2026-02-11 · Biomerieux - VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n
FDA Device · Class II · 2025-10-08 · Biomerieux - VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984
FDA Device · Class I · 2024-05-01 · Biomerieux
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0639-2019%22
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