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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 18,071 kits (US); 30,085 kits (OUS) Lot/code info: UDI-DI 00875197006674 All in-date lots

UPC codes

00875197006674

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.