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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 084 01 11 000
Date submitted: 1/31/2011
Manufacturer:Abbott
Device Type:ARCHITECT iVancomycin Reagent
Description:Reagents, Immunoassay, Therapeutic Drug, Antibiotic, Vancomycin
Medical Device Identifier:List Number 1P30 all lot numbers
Reason of Field Safety Corrective Action:Potential to generate falsely elevated results when using the ARCHITECT iVancomycin Reagent,
Remedy Action:Identify any affected product in your inventory. When using affected product, follow all sample handling instructions in the "Specimen Collection and Preparation for Analysis" section of the product's package insert.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, Riyadh (01) 2917222
Report Source:NCMDR
Source Ref. Number:778B7DD2662B7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments