FDA Device recall Z-1642-2022
T-Cell Xtend REF TTK.610 US
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of T-Cell Xtend REF TTK.610 US 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-1642-2022 |
| 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
T-Cell Xtend REF TTK.610 US
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: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001 |
|---|
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-1642-2022%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.