Model No:T-SPOT — Class III medical device recall Z-2977-2020
Terminated recall by Oxford Immunotec, reported 2020-09-23, distributed nationwide. Incorrect expiration date included in test kit labeling and/or in Substrate component label.
| Recall number | Z-2977-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oxford Immunotec, Abingdon, N/A, United Kingdom |
| Recall initiated | 2020-07-16 |
| Classified | 2020-09-16 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, IT, KR, KW, LV, NL, PH, SA, SE, SG, TR |
| Quantity | 125 units |
| Reason classes | labeling |
| Lot numbers | TFC2471883, TFC2481752, TFC2621768, TFC2621885, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC3361860 |
| Model numbers | T-SPOT.TB50, TB.50 |
Product
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
Reason for recall
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
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-2977-2020. 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.