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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 039 11 12 000
Date submitted: 11/12/2012
Manufacturer:Radiometer Medical
Device Type:IVD, ABL90 FLEX analyzer
Description:IVD, analyzer
Medical Device Identifier:Software V2.8 ABL90 FLEX
Reason of Field Safety Corrective Action:in case a scheduled QC measurement for some reason is aborted, the analyzer would not automatically re-run that level. This means that the analyzer skips that level altogether and the next level will be run according to the schedule eight hours later. The skipping of that level is not flagged.
Remedy Action:released a new software version for the ABL90 (V2.8 MR1)
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCMDR
Source Ref. Number:5DB8B50D70247
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Radiometer Medical (1).pdf