FDAMarch 25, 2021device
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
What to do
FDA enforcement status: Ongoing
Brands named
roche molecular systemsrocheroche molecular
UPCs
09211101190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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