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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 067 08 15 000
Date submitted: 8/13/2015
Manufacturer:Immunodiagnostic Systems Limited
Device Type:Insulin-like Growth Factor
Description:Instrumentation
Medical Device Identifier:Catalogue Number : BC1110
Lot : #27883
Reason of Field Safety Corrective Action:The CAL6-CALS calibrator binding range for kit BC1110 #27883 was 9.3 % when tested on 03 Dec 2014. The specification for this parameter is >12.5 %. The BC1110 kit #27883 is therefore outside the specification for the binding range between the CAL6 and CAL5 calibrators. Internal quality control (IQC) values were all within range prior to 20th Dec 2014. The BC1110 kit #27883 is currently in use and expires on 08 January 2015.
Remedy Action:Any unused product should be quarantined and returned to IDS immediately.
Athorized Representative/Importer/Distributor:Saudi Mais Co. For Medical Products
Report Source:NCAR
Source Ref. Number:UK-2015-07-28-153
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: ~8787342.pdf