PTS Panels Glucose Test Strips 의 안전성 경고

Safety alert

2013-04-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20130424.html

Recall of pts panels glucose test strips (with photo) the department of health (dh) today (april 23) directs a local medical device supplier, lynx technology limited (lynx) to recall one lot of the pts panels glucose test strips from consumers as the test strips may give falsely low blood glucose readings. the dh noticed through its surveillance of medical devices that the product's manufacturer, polymer technology systems, inc., has discovered through its product performance surveillance that one lot of the product (lot number: u117) showed falsely low blood glucose readings. a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. according to lynx, some 100 bottles of the affected lot of glucose test strips have been imported into hong kong and distributed to pharmaceutical companies, medical equipment companies and non-governmental organisations, etc. "so far, the dh has not received any local report of adverse events arising from use of the product," the spokesman said. members of the public who may have the affected lot of the test strips in their possession are advised to stop using the product and return their remaining inventory to the local supplier. lynx has set up a hotline 2568 1268 to answer public enquiries on recall arrangements. "for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their health-care professionals for advice as soon as possible," the spokesman added. the dh has informed relevant stakeholders about the recall and shall continue to liaise with the supplier on the follow-up actions. ends.