Recall archive / FDA device enforcement
T-SPOT.TB REF TB.300 US — FDA record Z-1641-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- T-SPOT.TB REF TB.300 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.
- Classification
- Class II
- Recalling firm
- OXFORD IMMUNOTEC LTD
- Quantity
- 81 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1641-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 7, 2022
- Recall initiation date
- Jul 7, 2022
- Center classification date
- Aug 26, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.