FDA (Devices) recall action 92056
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.
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.
Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.
Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.
Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.
Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.