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Oxford Immunotec recalls Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagno
Recalled September 23, 2020 · FDA recall Z-2976-2020 · Oxford Immunotec
Hazard
Incorrect expiration date included in test kit labeling and/or in Substrate component label. · FDA Class III
Units
583 units
Sold at
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.
Description
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
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.
Manufacturer(s)
Oxford Immunotec
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →