T-Cell Xtend REF TTK — Class II medical device recall Z-1642-2022
Ongoing recall by OXFORD IMMUNOTEC LTD, reported 2022-09-07, distributed in AL, CA, DC, GA, IN, OR, WA. Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 deg
| Recall number | Z-1642-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OXFORD IMMUNOTEC LTD, Abingdon, United Kingdom |
| Recall initiated | 2022-07-07 |
| Classified | 2022-08-26 |
| Reported by FDA | 2022-09-07 |
| Distributed | AL, CA, DC, GA, IN, OR, WA |
| Quantity | 47 units |
| UPC / GTIN / UDI-DI | 15051716000022 |
| Lot numbers | 1001 |
| Model numbers | TTK.610US |
Product
T-Cell Xtend REF TTK.610 US
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1642-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.