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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 037 03 12 000
Date submitted: 3/10/2012
Manufacturer:Eumed Biotechnology Co., Ltd
Device Type:EUKARE Blood Glucose Monitoring System, Blood Glucose Test Strip
Description:Test strip, Glucose, Monitoring
Medical Device Identifier:Lot/batch no.: TS14DD1F1002 and TS16DD1H2814
Reason of Field Safety Corrective Action:Certain lots of glucose test strips used with EUKARE glucose measuring system may give falsely high blood glucose readings, which can lead patients to try to lower their blood glucose when it is unnecessary, or fail to treat low blood glucose levels.
Remedy Action:Test strips from the affected lots should not be used. They can be replaced or refunded by the manufacturer upon return
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:TW-2012-03-01-001
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments