Ki67-MM1 Bond Ready To Use, An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00344-1

Class I

2015-04-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00344-1

Leica biosystems recently became aware that some lot numbers do not consistently perform as expected and in some instances have exhibited weaker than expected staining. a false negative result could potentially result in the underestimation of the aggressiveness of a neoplasm, the mis-classification of a neoplasm, or failure to distinguish a benign process from a malignant one. any of these could result in the application of inappropriate treatment or delay in therapy. laboratories that follow procedures outlined in the products’ instructions for use (ifu) would identify the weak staining or negative staining in the tissue control.

Leica Biosystems is advising the users to return any unused product for a credit note. Leica Biosystems is advising users that clinical interpretation of staining or its absence should be evaluated within the context of the patient's clinical history and other diagnostic tests . A review of patient results may be warranted at the discretion of the pathologist. This action ha been closed-out on 31/08/2016.