Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Model No:T-SPOT.TB8 Recalled by Oxford Immunotec Due to Incorrect expiration date included in test kit labeling...

Date: July 16, 2020
Company: Oxford Immunotec
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Oxford Immunotec directly.

Affected Products

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.

Quantity: 583 units

Why Was This Recalled?

Incorrect expiration date included in test kit labeling and/or in Substrate component label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Oxford Immunotec

Oxford Immunotec has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report