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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 004 05 13 000
Date submitted: 5/5/2013
Manufacturer:Abbott Diabetes Care Div Abbott Laboratories Inc
Device Type:Analyzers, Point-of-Care, Whole Blood, Glucose, Precision XceedPro Blood Glucose and β-Ketone Monitoring Systems
Description:Analyzers, Point-of-Care, Whole Blood, Glucose
Medical Device Identifier:Precision XceedPro Blood Glucose and β-Ketone Monitoring Systems
Reason of Field Safety Corrective Action:1. A small number of Precision XceedPro Blood Glucose Test Strips lots produce control solution results out of range and higher than expected percentage Coefficient of Variation and Standard Deviation with controls. This issue does not affect patient blood glucose or β-ketone results, as confirmed through the manufacturer internal testing of retained strips and performance monitoring program. 2. Precision XceedPro Monitors with serial numbers beginning with “KC” do not fully support a subset of the following barcode types: Interleaved 2 of 5 (I 2 of 5), Code 128 and Code 39. As stated in label copy, if you cannot scan a barcode using the barcode scanner, the data entry keypad on your Precision XceedPro Monitor allows you to manually enter identification numbers and letters
Remedy Action:Identify any affected product in your inventory. If you cannot scan a bar code using the bar code scanner, you may manually enter identification numbers and letters using the data entry keypad on the monitor. If you observe the above problems, contact an Abbott Diabetes Care representative to schedule a firmware update for the monitor. Abbott states that you may continue to use the above systems to test patients and to test with controls.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, Jeddah, (02) 651-1077
Report Source:NCMDR
Source Ref. Number:70454101AD1A4
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Abbott.pdf