medical Class II Updated 2019-04-10

Beckman Coulter Inc. recalls UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinic

Recalled Product

UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102


Hazard / Issue

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Systems running software versions: 5.2, 5.3.0, 5.3.1.
View official government recall

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