# FDA recall Z-2976-2020

> **Oxford Immunotec** · Class III · device recall initiated 2020-07-16.

## Product

Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - 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.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-2976-2020
- **Recalling firm:** Oxford Immunotec
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-16
- **Report date:** 2020-09-23
- **Termination date:** 2021-09-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2976-2020

## Citation

> AI Analytics. FDA recall Z-2976-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2976-2020. Source: US FDA. Licensed CC0.

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