FDA (Devices) recall action 86096
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.
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
The agency’s own wording, quoted from the enforcement report.
Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.
Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.