FDAMarch 31, 2023device
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
What to do
FDA enforcement status: Ongoing
Brands named
sd biosensor
UPCs
88747300020708800111707728
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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