UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01093-1

Class II

2016-08-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01093-1

Beckman coulter has identified the possibility of specimen mis-identification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id. results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs:- the primary identifier is tube position id.- a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist.- the patient control sample is analysed using cassette presentation, but that tube does not contain a barcode-labelled specimen id or the label cannot be read.Upon analysis, the results from the analysed patient control tube will be associated with the patient sample that was pending on the worklist and not the patient control file.

Beckman Coulter is advising users to ensure there are no pending or active test orders in the worklist before analysing a patient control with a Tube Position ID. Beckman Coulter is investigating the issue in order to determine a resolution.