FDA (Devices) recall action 85731
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.
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
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 1,555 IMMULITE 2000 analyzers because flexible tubing can crack, causing liquid waste leaks and slip hazards.
Siemens Healthcare Diagnostics Inc. is recalling 2,925 IMMULITE 2000 XPi Immunoassay Systems because flexible tubing can crack, causing liquid waste leaks and slip hazards.