VerifyNow IIb/IIIa 25-Test and 10-Test Kits 의 안전성 경고

Safety alert

2014-03-04

2014-03-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140304.html

Medical device safety alert: accumetrics verifynow iib/iiia 25-test and 10-test kits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning verifynow iib/iiia 25-test and 10-test kits [product codes: 85011 and 85310; reference number: ivd14.014; capa 13-014] manufactured by accumetrics. during its surveillance, the manufacturer has determined that the affected verifynow iib/iiia test kit lots may result in the reporting of an erroneous low platelet aggregation unit (pau) result. corrective actions are being implemented to prevent these issues from affecting future lots of verifynow iib/iiia test kits. the manufacturer has not received any reports of adverse events for these issues. according to the manufacturer, a lower than actual or expected pau values may contribute to excess administration of iib/iiia anti-platelet agents, which has the potential to lead to an adverse event. typically, higher doses of anti-platelet agents are associated with higher risk of bleeding. the manufacturer advises all affected users to check their inventory to determine if they have any affected verifynow iib/iiia test kits. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 march 2014.