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OXFORD IMMUNOTEC LTD recalls T-Cell Xtend REF TTK.610 US
Recalled September 7, 2022 · FDA recall Z-1642-2022 · OXFORD IMMUNOTEC
Hazard
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. · FDA Class II
Units
47 units
Sold at
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Description
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.
Product
T-Cell Xtend REF TTK.610 US
Manufacturer(s)
OXFORD IMMUNOTEC LTD
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →