FDA (Devices) recall action 67599
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.
Marketing the devices outside 510(k) requirements
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.
AMS Diagnostics is recalling 13 Uric Acid test kits because they were marketed outside FDA 510(k) requirements.
AMS Diagnostics is recalling 116 AMS AST kits because they were marketed outside FDA 510(k) requirements. The recall covers nationwide distribution.
AMS Diagnostics is recalling 167 BUN Urea Nitrogen kits because they were marketed outside FDA 510(k) requirements.