OXFORD IMMUNOTEC LTD recalls T-SPOT.TB REF TB.300 US

Recall date

July 7, 2022

Source

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

Recall number

Z-1641-2022

FDA classification

Class II

Brand / firm

OXFORD IMMUNOTEC LTD

Sold / distributed

U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

T-SPOT.TB REF TB.300 US