SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 160 09 12 000
Date submitted:	9/25/2012

Manufacturer:	Radiometer Medical
Device Type:	IVD, analyzer ABL90 FLEX
Description:	IVD, analyze
Medical Device Identifier:	ABL90 (see attached)
Reason of Field Safety Corrective Action:	The linearity of the glucose is dependent on the oxygen tension of the sample. This dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase. Very low pO2 levels can influence the linearity of the glucose sensor. As a consequence of this Glu results will no longer be reported when the pO2 value is below 25 mmHg.
Remedy Action:	Upgrade the software in all ABL90 FLEX analyzers to V2.8. Provide each customer with the customer letter as well as a copy of the Update kits for the Operator’s and Reference Manuals.
Athorized Representative/Importer/Distributor:	Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:	NCMDR
Source Ref. Number:	9BB13938BA277
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Radiometer Medical (3).pdf

View History