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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 001 08 12 000
Date submitted: 8/1/2012
Manufacturer:Abbott Laboratories Inc
Device Type:IVD, ARCHITECT Toxo IgG reagent
Description:IVD, 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.
Remedy Action: 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.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:1FCA1F5CD0234
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories Inc.pdf