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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 051 01 16 000
Date submitted: 1/13/2016
Manufacturer:Bio Rad.
Device Type:D-10 Rack Loader
Description:allows loading up to 50 samples for walk-away capability
Medical Device Identifier:Catalog No. 220-0600
Reason of Field Safety Corrective Action:It has come to our attention that there is a potential to assign a patient result to an incorrect sample ID when running in the D-10 Rack Loader configuration.
Remedy Action:While reviewing results, please verify that the number of results equals the total number of samples run. If there is a discrepancy, identify the rack with the missing result, rerun all samples from that rack, and check the laboratory information system (LIS) results.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:05687C1862163
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Bio Rad..pdf