FDA (Devices) recall action 88261
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect 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.
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.