UniCel DxH 600 & 800 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-01651-1

Class II

2016-12-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01651-1

Beckman coulter has determined that additional clarification for the blast suspect messages is necessary. in certain 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. in these situations there could be a delay in the diagnosis and treatment of conditions associated with blasts in the peripheral blood.

Beckman Coulter is providing users with information about limitations of the of the UniCel DxH 600 & 800 systems with respect to the flagging and detection of blasts in some blood samples. Detailed information will be provided in a customer letter and will also be temporarily available within the online ReadMefile, B44444AE, available on the Beckman Coulter website. Revised instructions that include this information will be available in March 2017. The information provided should be discussed with the Medical Director with respect to looking-back of previous patient results. In addition, the possibility of false negatives and the need for blood films should be considered.