TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00632-1

Class II

2016-05-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00632-1

This recall has been initiated as a limited number of sealed test strip vial boxes from the affected trueresult blood glucose test strip batch may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can adversely affect the strips performance. in particular, test strips exposed to the environment may provide falsely low blood glucose results. falsely low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.Action based on falsely low results may raise blood glucose levels further, resulting in potentiated hyperglycemia which may require medical intervention.

Nipro is advising users to inspect stock and quarantine any remaining stocks of the affected batch for return. This action has been closed-out on 03/02/2017.