TRUEtrack and TRUEtest Blood Glucose Test Strips 의 안전성 경고

Safety alert

2016-07-20

2016-07-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160720.html

Medical device safety alert: truetrack and truetest blood glucose test strips the health canada has posted a medical device safety alert concerning the truetrack and truetest blood glucose test strips, manufactured by trividia health, inc. the model and lot numbers affected by this issue are described below: truetrack blood glucose test strips [model number: a3i20-80, a3i20-81; lot number: rs4567ica, rs4704ica] truetest blood glucose test strips [model number: e3i20-80, e3i20-81; lot number: ps2284ica, ps2316ica, ps2335ica] a limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can affect strip performance. in particular, test strips exposed to the environment may provide incorrect low blood glucose results. according to the manufacturer, inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment. for details, please refer to the health canada’s websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59384r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 july 2016.