FDA (Devices) recall action 83175
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.
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
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.
Randox Laboratories is recalling RX Daytona instruments due to a sensor malfunction that caused internal wire melting and scorch damage.
Randox Laboratories is recalling 27 RX Imola instruments after a sensor malfunction caused internal wire melting and scorch damage.