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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 127 11 16 000
Date submitted: 11/22/2016
Device Type:ARCHITECT Toxo IgM
Description:Reagent, IVD
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.
Remedy Action:• 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.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:71419EBF1D22C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf