FDA (Devices) recall action 73283
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.
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
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.
Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.
Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.
Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.