FDA Device recall Z-1059-2022
VITEK 2 Systems and VITEK 2 with MYLA
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of VITEK 2 Systems and VITEK 2 with MYLA by Biomerieux, citing software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1059-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-29 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | NC |
Product
VITEK 2 Systems and VITEK 2 with MYLA.
Reason
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
Identifiers
| code_info | VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1059-2022%22
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