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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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NCMDR Recall

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Reference Number:	mdprc 020 09 12 000
Date submitted:	9/2/2012

Manufacturer:	Radiometer Medical
Device Type:	IVD, AQT90 FLEX analyser
Description:	IVD, analyser
Medical Device Identifier:	AQT90 FLEX with software versions below V8.3.40 and using the HL7 2.5 communication protocol
Reason of Field Safety Corrective Action:	The patient result mix-up occurs if: • The communication line is interrupted or disconnected • Two or more patient results are queued for transmission • The communication is re-established and the analyzer transmits the results in the queue. In this situation the first result will be transmitted with the correct patient ID, whereas succeeding results in the queue will be appended to the first patient ID.
Remedy Action:	Upgrade the software in remaining AQT90 FLEX to V8.3.40.
Athorized Representative/Importer/Distributor:	Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:	NCMDR
Source Ref. Number:	4099F81173255
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Radiometer Medical (3).pdf

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