FDA (Devices) recall action 76619
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
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 Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.