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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 116 12 12 000
Date submitted: 12/18/2012
Manufacturer:Abbott Laboratories Inc
Device Type:IVD, ARCHITECT 25-OH Vitamin D
Description:IVD, ARCHITECT 25-OH Vitamin D
Medical Device Identifier:List Number 3L52 (all lots) For lot number see attached
Reason of Field Safety Corrective Action:potential to generate falsely elevated or falsely depressed results when the assay is used with the attached ARCHITECT Reaction Vessel (RV) (LN 7C15-01) lots.
Remedy Action:Discontinue use and destroy any remaining inventory of the ARCHITECT RV lots listed above according to your laboratory procedures. • If the ARCHITECT RV lots above are the only lots available in your laboratory, immediately order a new lot as replacement RV lots are available. o Discontinue testing ARCHITECT 25-OH Vitamin D until a new RV lot arrives
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh (01) 4780555
Report Source:NCMDR
Source Ref. Number:A73E9199AD2BC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories Inc.pdf