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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 127 11 16 000
ARCHITECT Toxo IgM
Medical Device Identifier:
List Number (LN): 6C20-25, 6C20-35 .
Lot Number: 64245LI00, 66063LI00, 67003LI00, 68443LI00, 69252LI00, 70171LI00, 64248LI00, 66066LI00, 67006LI00, 68444LI00, 69253LI00, 70174LI00
Reason of Field Safety Corrective Action:
For the ARCHITECT Toxo IgM assay an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for the lot numbers above. These sample types share the commonality of low total IgM titer.
• Please review this letter with your Medical Director
• Additional testing with a secondary method is recommended to confirm reactive results (≥ 0.60 Index or ≥ 1.00 S/CO) for samples from immunocompromised patients or newborns or cord blood samples and other samples with expected low IgM concentrations.
• Please retain this letter for your laboratory records.
Medical supplies & Services Co.Ltd Mediserv
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.