FDA (Devices) recall action 91482
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Roche Molecular Systems recalls cobas SARS-CoV-2 & Influenza A/B assay kits used in clinical laboratories. The kits may produce false negative Influenza A results, potentially delaying accurate diagnosis.
Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.