AQUIOS CL Flow Cytometry System. An in vitro medical device. 의 리콜

Recall

RC-2018-RN-00098-1

Class I

2018-02-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00098-1

Aquios cl system will associate the wrong sample id with results in the event the following sequence occurs: -the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted, places a specimen tube in single tube loader, and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the “details” column on running screen changes to “prepping” for that sample. - user removes the first specimen tube and replaces with a different specimen tube. this issue was discovered internally during a verification test. there have been no reported similar events from the field.

Beckman Coulter has released the software correction for this issue at the end of January 2018. A Beckman Coulter Field Service Engineer will contact users to schedule the installation of the software upgrade. In the interim, users are advised to follow the steps and warnings outlines in the IFU when running STAT specimens to avoid sample mis-identification. When running multiple specimen via the single tube loader, wait for the currently loaded specimen to be in the "incubating" status in the "details" column on the Running screen before selecting the STAT button or attempting to cancel the run.