Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00632-1 |
Product Name/Description |
TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD)
Item Number: E4i08-81FD
Expiry Date: 25/06/2018
Batch Number: KS1741
ARTG Number: 180121 |
Recall Action Level |
Consumer |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
18/05/2016 |
Responsible Entity |
|
Reason/Issue |
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. |
Recall Action |
Recall |
Recall Action Instructions |
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. |
Contact Information |
1800 451 737 - Nipro Customer Service |