FDANovember 16, 2021device
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
What to do
FDA enforcement status: Ongoing
Brands named
roche molecular systemsrocheroche molecular
UPCs
0761333610009707341920190
Recall history
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