# FDA recall Z-1641-2022

> **OXFORD IMMUNOTEC LTD** · Class II · device recall initiated 2022-07-07.

## Product

T-SPOT.TB REF TB.300 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.

## Distribution

U.S.: AL, CA, DC, GA, IN, OR, and WA  O.U.S.: None

## Key facts

- **Recall number:** Z-1641-2022
- **Recalling firm:** OXFORD IMMUNOTEC LTD
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-07
- **Report date:** 2022-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Abingdon, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2022

## Citation

> AI Analytics. FDA recall Z-1641-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1641-2022. Source: US FDA. Licensed CC0.

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