FDA Device recall Z-0439-2022
VIDAS SARS-COV-2 IgG, Ref 423834-01
- FDA Device
- Class II
- ongoing
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of VIDAS SARS-COV-2 IgG, Ref 423834-01 by Biomerieux, citing bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0439-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-22 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VIDAS SARS-COV-2 IgG, Ref 423834-01
Reason
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Identifiers
| code_info | UDI 03573026620745, Lot #: 1008671430, 1008763910 |
|---|
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-0439-2022%22
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