Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00069-1

Class II

2016-01-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00069-1

Leica biosystems recently became aware that the product / detection kit combinations identified may not provide adequate staining when used according to the instructions for use. if the products are used according to their instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.

Leica Biosystems is advising users to discontinue use of the listed antibodies / probes with the specified detection kits. There are alternative kits available for use. Leica is advising that there is no requirement for a review of previously reported results if appropriate positive controls were used.