medical Class II Updated 2021-04-21

Roche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents,

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers
View official government recall

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