Class II — OXFORD IMMUNOTEC LTD
| Recalling firm | Oxford Immunotec Ltd |
|---|---|
| Registered facility | OXFORD IMMUNOTEC LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | T-SPOT.TB REF TB.300 US |
| Quantity | 81 units |
| Distribution | U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None |
| Initiated | 2022-07-07 |
| Classified | 2022-08-26 |
| Recall number | Z-1641-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OXFORD IMMUNOTEC LTD (Z-1641-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90654/
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