FDA recall Z-1413-2021

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

Reason for recall

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

Distribution

Nationwide WorldWide

Key facts

Status

Ongoing

Initiation date

2021-03-25

Report date

2021-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Branchburg, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1413-2021