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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 027 12 14 000
Date submitted: 12/2/2014
Manufacturer:HemoCue A B
Device Type:HemoCue Glucose 201 Microcuvettes
Description:IVD, Glucose measurements
Medical Device Identifier:Model: 110716
Lot/batch no.: 1407345
Reason of Field Safety Corrective Action:The manufacturer HemoCue AB has become aware of that parts of lot 1407345 of the HemoCue Glucose 201 Microcuvette have been produced without enzymes in the reagent. Due to lack of enzymes, no reaction will take place in the microcuvette when filled with whole blood.
Remedy Action:The manufacturer has initiated a Field Safety Corrective Action concerning this lot and is advising the users to return the affected items.
Athorized Representative/Importer/Distributor:Raez Environmental System & Advanced Technologies
Report Source:NCAR
Source Ref. Number:INC-SE-14-11-000029
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: SE-2014-11-27-029_FSN_281114.pdf