Mylife Pura blood glucose strips 의 안전성 경고

Safety alert

2012-02-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20120223.html

Recall of mylife pura blood glucose strips in france the department of health (dh) today (february 22) drew the public's attention to the recall of certain lots of a blood glucose test strip in france. the affected product is mylife pura (box of 100) manufactured by bionime corporation. the test strips may give falsely high blood glucose readings. the dh was informed by the french medical device regulatory authority, agence francaise de sécurité sanitaire des produits de santé (afssaps), about the recall. according to afssaps, the problem came to their notice when several reports of overestimation of blood glucose levels were received. further investigation revealed that the problem was due to the accidental opening of the unsealed vials of the test strips during transportation from the distributor in france to the pharmacies. as the test strips are very sensitive to air exposure, they may lose performance and give falsely high readings. the manufacturer has since then taken preventive action by starting to seal all the vials with a protective film. a spokesman for the dh explained that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia - indeed, such a case has been reported in france. so far, the dh has not received any local report of adverse events arising from use of the product. although there is currently no readily available evidence to suggest that the affected product has ever been exported to hong kong, the dh is following up with the manufacturer to verify that this is indeed the case. meanwhile, as a precautionary measure, members of the public who may have the above product in their hands are advised to stop using any vials which came unsealed and surrender them to the dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai. "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 said. ends.