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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 036 02 13 000
Date submitted: 2/6/2013
Manufacturer:Radiometer Medical
Device Type:Analyser, ABL90 FLEX sensor cassette
Description:Analyser, blood gas, general purpose
Medical Device Identifier:Lot/batch no.: R0124N088 to R0124N129
Reason of Field Safety Corrective Action:The expiration date for the ABL90 FLEX SC is 4 months from the production date, including the 30 day in use lifetime . SC90 946-008R0124 (42 cassettes #88-129) were produced on 2012-10-23, while the labels were erroneously printed with the expiration date 2013-10-23. The chip in the SC is encoded with the date from the barcode label, and is therefore also incorrect
Remedy Action:Radiometer has requested the affected customers to return any sensors in stock or in use
Athorized Representative/Importer/Distributor:Salehiya Trading Est, Jeddah, 01-2628939
Report Source:NCAR
Source Ref. Number:DK-2013-01-31- 023
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments