Access BR Monitor. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00500-1

Class II

2017-04-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00500-1

Beckman coulter has been informed that a study completed by the french competent authority ansm showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. in this preliminary study, at the cutoff of 31.3 u/ml designated in the access br monitor ifu, the assay achieved a sensitivity of 63% and a specificity of 100% for patients in non-remission.As a result, beckman coulter is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned to be available by the third quarter of 2017.

Beckman Coulter is advising users that they are currently evaluating the Access BR Monitor cutoff. Users are reminded of the limitations of the assay which are included the current IFU and detailed in the customer letter. These relate to the intended use of the assay as an aid in the management of breast cancer patients and not as a screening tool, the interpretation of CA 15-3 antigen concentration results and the laboratory's establishment of reference ranges to assure proper representation of specific populations.