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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 028 03 11 000
Date submitted: 3/7/2011
Manufacturer:Abbott Diagnostic International Ltd
Device Type:ARCHITECT Clinical Chemistry Analyser
Description:Processing Module System For In Vitro Diagnostic Use
Medical Device Identifier:Product Name: ARCHITECT c4000, ARCHITECT c8000, ARCHITECT c16000. List Number: 2P24-01, 2P24-40, 1G06-11, 3L77-01 Instrument Serial Numbers: c460004 to c460014, c460016 to c460019, c400069, c400071 to c400099, c400146, c400219, c800307, c800742, c801237, c801462, c802378, c803060, c803061, c803062, c803063, c1600284
Reason of Field Safety Corrective Action:Abbott Diagnostics has received information from Toshiba, the supplier of the ICT Pre-Amp Board, indicating the board’s photo couplers may degrade over time. Affected ARCHITECT cSystems will generate repeated calibration failures for the ICT analytes (sodium, potassium, and chloride).
Remedy Action:Abbott has identified the systems which may contain the affected boards, and will be making arrangements with you to replace the board at no charge. All replacements are expected to be completed within the next three months.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh (01) 4780555
Report Source:NCMDR
Source Ref. Number:60FDA1632F290
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: FA03MAR2011_LTR.pdf