FDA (Devices) recall action 69228
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.
The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
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.
Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer due to damage that can cause electric shock.
Siemens Healthcare Diagnostics is recalling approximately 4,200 external power supply adapters for the Clinitek Status+ urine analyzer due to damage that can cause electric shock.
Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer because they are damaged and can cause electric shock.