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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 078 05 14 000
Date submitted: 5/18/2014
Device Type:ARCHITECT EBV VCA IgM Controls
Description: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.
Remedy Action:• 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.

Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, (012) 651-1077
Report Source:NCMDR
Source Ref. Number:96DC860914215
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf