Roche Molecular Systems, Inc.: The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

Agency Publication Date: February 7, 2023

Affected Products

Product: cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

UDI-DI 00875197006674 All in-date lots

Product: cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

UDI-DI 00875197006827 All in-date lots

Product: cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

UDI-DI 00875197006773 All in-date lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91482

Status: Active

Manufacturer: Roche Molecular Systems, Inc.

Manufactured In: United States

Units Affected: 3 products (18,071 kits (US); 30,085 kits (OUS); 9,948 OUS only; 727 kits OUS only)

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Sources: FDA iRES · Raw API Response

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