FDA Device recall Z-1107-2020
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit by Biomerieux, citing two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1107-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-10 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Reason
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
Identifiers
| code_info | US Model 30217-01 Lot 1007410330 and 1007393380 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1107-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.