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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall

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Reference Number:	mdprc 034 07 13 000
Date submitted:	7/4/2013

Manufacturer:	Radiometer Medical
Device Type:	IVD: Blood gas electrode, oxygen, pO2 membrane units for ABL5/50/500
Description:	An electrical conducting device used to determine the concentration of oxygen (O2) in a sample of blood
Medical Device Identifier:	D999 Membrane box for E909 pO2 electrode for ABL5/50/5XX, 942-042, R0971
Reason of Field Safety Corrective Action:	RADIOMETER has recently become aware that one lot of membrane boxes has been produced using an incorrect electrolyte solution. Some of these membranes have been found to calibrate and provide valid results on the analyzer for a few days (4-6 days), before Cal 2 fails on zero point. When this happens the membrane units will have a rapidly increasing positive bias until they are rejected by the following Cal 2. Cal 2 is run every 4 hours, and within this time slot there is a possible risk of obtaining wrong measuring results
Remedy Action:	1) Please check your inventory and remove any D999 Membrane Boxes from the affected lot. 2) Please discard all membrane boxes from the affected lot in your possession.
Athorized Representative/Importer/Distributor:	Salehiya Trading Est., Riyadh, (011) 2628939
Report Source:	NCAR
Source Ref. Number:	DK-2013-07-01 - 029
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:	No Attachments

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