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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 117 02 14 000
Date submitted: 2/19/2014
Manufacturer:Abbott
Device Type:ARCHITECT Intact PTH assay
Description:ARCHITECT Intact PTH assay reagent and calibrator
Medical Device Identifier:ARCHITECT Intact PTH Assay List Number 8K25 (see attached for impacted lots) Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10). More information on the affected products is provided in the attached letter
Reason of Field Safety Corrective Action:a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples.
Remedy Action:Immediately discontinue use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to your laboratory procedures. Please see the attached letter for more information on the necessary actions.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division
Report Source:NCMDR
Source Ref. Number:B6614CADFC30C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf