FDA-Device2021-04-21Class II
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
Roche Molecular Systems, Inc.
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
Sold states
Nationwide WorldWide
Affected count
US: 143,823 kits Ex-US: 57,219 kits
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1413-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief