FDA-Device2022-09-07Class II
T-SPOT.TB REF TB.300 US
OXFORD IMMUNOTEC LTD
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.
Sold states
U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Affected count
81 units
Manufactured in
143 Park Road, Abingdon, United Kingdom
Products
T-SPOT.TB REF TB.300 US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2022Don't want to check this manually?
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