FDA (Devices) recall action 68271
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.
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected
The agency’s own wording, quoted from the enforcement report.
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a potential for biased results when specific Multiple Window codes are used.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software issue that may cause biased results when using Multiple Window codes.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.