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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 078 05 14 000
ARCHITECT EBV VCA IgM Controls
IVD, determination of the immune status
Medical Device Identifier:
List Number: 3P66-10 Lot Number: 38938LI00 Expiration Date: 22-Sep-2014
Reason of Field Safety Corrective Action:
The Positive Control of the ARCHITECT EBV VCA IgM Control lot 38938LI00 has reduced stability. This may result in a higher than expected number of out of range low values. The Negative Control is not impacted.
• Determine if you are currently using or have inventory of Control lot 38938LI00.
• If the ARCHITECT EBV VCA IgM control values are within package insert range, the associated test results are valid. If the control values are outside your internal specifications, please follow your laboratory procedures.
• If the ARCHITECT EBV VCA IgM control values are outside package insert range, discontinue use of lot 38938LI00 and destroy any remaining inventory of this lot according to your laboratory procedures.
• Immediately contact Customer Support for ordering replacement material.
Abbott Diagnostics Division, (012) 651-1077
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.