freestyle and freestyle lite blood glucose test strips 의 안전성 경고

Safety alert

2013-11-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131125a.html

Recall of certain lots of freestyle and freestyle lite blood glucose test strips the department of health (dh) today (november 25) drew public attention to abbott diabetes care's recall of certain lots of its two brands of blood glucose test strips, namely freestyle and freestyle lite, due to the potential for giving erroneously low blood glucose results when using in conjunction with certain brands of blood glucose meters also manufactured by the company. the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the therapeutic goods administration (tga) of australia involving two lots of freestyle lite blood glucose test strips (lot number: 1366540 and 1366621). according to tga, the two affected lots have the potential to give readings that are incorrectly low when used in conjunction with freestyle papillon mini blood glucose meters. when conducting follow-up to tga's alert, dh noticed that abbott diabetes care in the us has posted a recall notice on its company website, announcing that certain lots of freestyle and freestyle lite blood glucose test strips (lot numbers: 1281732, 1283345, 1283603, 1285007, 1350414, 1363015, 1363109, 1363321, 1365056, 1365920, 1365921, 1365934, 1366006, 1366111, 1366337, 1366347, 1366515, 1367917, 1373262 and 1374907) may also produce falsely low blood glucose results when they are used with freestyle blood glucose meters, freestyle flash blood glucose meters and the freestyle blood glucose meter built into the omnipod system. 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. "although preliminary enquiry with the local supplier, abbott laboratories limited, reveals no evidence of the affected products having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the devices or test strips from abroad or from internet purchase," the spokesman remarked. "dh will continue to follow up with the supplier to further verify whether other brands and lots are affected and their distribution," the spokesman said. so far, the dh has not received any local report of adverse events arising from use of the affected products. people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman urged. the company has set up a customer service hotline 5808 4196 to answer related enquiries. ends.