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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 041 02 11 000
Date submitted: 2/19/2011
Manufacturer:Abbott Laboratories
Device Type:ARCHITECT 25-OH Vitamin D Reagent
Medical Device Identifier:List Number: 3L52-25 Lot Number: 01110L000
Reason of Field Safety Corrective Action:Abbott has become aware of an error in the maximum on-board stability time displayed on the ARCHITECT for the 100-test kit size of ARCHITECT 25-OH Vitamin D List 3L52-25 lot 01110L000. The barcode error eliminates the ability of the instrument to prevent the use of reagents that are on board the instrument greater than 7 days (168 hours).
Remedy Action:Please manually track on board storage time of reagent lot 01110L000 whether you leave the kit on board continuously or remove the kit each day after testing. Discard the reagent kit after 168 hours of testing time has elapsed on board the ARCHITECT.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, Riyadh (01) 2917222
Report Source:NCMDR
Source Ref. Number:D184638B4E291
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: FA11FEB2011_Letter[1].pdf