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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 001 08 12 000
Abbott Laboratories Inc
IVD, ARCHITECT Toxo IgG reagent
Medical Device Identifier:
List Number: 6C19-25 Lot Numbers: 15070LI00 and 15070LI01
Reason of Field Safety Corrective Action:
ARCHITECT Toxo IgG reagent are showing reduced specificity which may cause a shift to higher IU/mL values leading to increased grayzone and/or reactive results.
Determine if you are currently using or have inventory of lots 15070LI00 and/or 15070LI01, immediately contact Customer Support for replacement material. Discontinue use of lots 15070LI00 and/or 15070LI01 and destroy any remaining inventory of these lots according to your laboratory procedures.
Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Abbott Laboratories Inc.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.