Roche Molecular Systems, Inc.: 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

Agency Publication Date: April 13, 2021

Affected Products

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

All lot numbers

Lot Numbers:

numbers

Product: cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

All serial ID numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87622

Status: Active

Manufacturer: Roche Molecular Systems, Inc.

Manufactured In: United States

Units Affected: 2 products (US: 143,823 kits Ex-US: 57,219 kits; US: 5,430 units ; OUS 1528 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Medium RiskFDA Device