FDA (Devices) recall action 76044
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.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
The agency’s own wording, quoted from the enforcement report.
Beckman Coulter is recalling the UniCel DxH 800 Cellular Analysis System because it may fail to detect blasts in some blood samples.
Beckman Coulter is recalling the DxH 600 Cellular Analysis System because it may fail to detect blasts in some blood samples.