FDA Device recall Z-1643-2022
AIM-V Medium REF AV.200/500
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of AIM-V Medium REF AV.200/500 by Oxford Immunotec, citing due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1643-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-07 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oxford Immunotec |
| Distribution | AL, CA, DC, GA, IN, OR, WA |
Product
AIM-V Medium REF AV.200/500
Reason
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Identifiers
| code_info | Model/Catalog Number: AV.200/500 UDI-DI Code: Not yet assigned Lot Number: 100380 |
|---|
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-1643-2022%22
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