TheraSphere Yttrium 90 Glass Microspheres 의 안전성 경고

Safety alert

2015-09-23

2015-09-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923b.html

Medical device safety alert: biocompatibles uk therasphere yttrium 90 glass microspheres medical device manufacturer, biocompatibles uk (btg), has issued a medical device safety alert concerning its therasphere yttrium 90 (y-90) glass microspheres. the affected products are identified as follows:- lot number: 1599211; manufacturing date: 03-sep-2015; calibration date: 06-sep-2015; expiry date: 18-sep-2015 the manufacturer has recently become aware, via a customer complaint, of the mislabeling of one dose vial of therasphere y-90 glass microspheres lot 1599211 that was distributed in hong kong. the therasphere vial was labeled 10 gbq and the actual dose was 5 gbq (total radioactivity was incorrect). mislabelling of the therasphere y-90 glass microspheres may result in under- or over-dosing of the patient resulting in the patient not receiving their prescribed dose. under-dosing could result in lack of efficacy, and over-dosing could result in non-target tissue radiation. the manufacturer advises users to verify the accuracy of the dose measurement prior to administration. this recommendation is consistent with the therasphere training and reference material that the manufacturer provides to each user. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.