HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2014-RN-01292-1

Class I

2014-12-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01292-1

Vials manufactured prior to june 2014 from the provided batch numbers may exhibit a yellow / brownish colour after reconstitution (yellow colour or darker) instead of the typical white to off-white colour. vials exhibiting this yellow / brownish colour were observed to cause prolonged clotting times, with several reports of controls being outside of the established ranges. if an affected vial is used with a patient sample, a significant shift in inr greater than 10% could occur with the potential to alter subsequent medical treatment.

Werfen is advising their customers not to use any vials identified as part of this recall, discard all boxes of potentially affected lot numbers of product. It is recommended that previously reported test results are reviewed under the supervision of the Medical Director. This acion has been closed-out on 26/08/2016.