Oxford Immunotec recalls Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagn…

Recall date

July 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2977-2020

FDA classification

Class III

Brand / firm

Oxford Immunotec

Sold / distributed

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, Sw…

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.