Access BR Monitor used with the Access family of Immunoassay systems. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01360-1

Class II

2017-10-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01360-1

In april 2017 (tga reference rc-2017-rn-00500-1) beckman coulter advised customers of issues with the access br monitor relating to results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).As a follow up, beckman coulter will update the access br monitor instructions for use (ifu). the updated ifu will reflect the 95th percentile upper reference limit (url) value for a healthy population, which was determined to be 23.5 u/ml. there is no change to the access br monitor assay.

Beckman Coulter is advising users of the updated 95th percentile upper reference limit (URL) value for a healthy population, which is 23.5 U/mL. Beckman Coulter is recommending that users review the contents of this letter with the Laboratory Medical Director. This URL change may mean that some patient test results should be reassessed depending upon how the URL is established by the laboratory.