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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 159 09 12 000
Date submitted:	9/25/2012

Manufacturer:	Radiometer Medical
Device Type:	analyzers, AQT90 FLEX
Description:	IVD, analyzers
Medical Device Identifier:	AQT90 FLEX: 393-838R0143N0001 Cup wash unit: 903-119 (shipped as of October 31)
Reason of Field Safety Corrective Action:	The root cause for the carry-over has been identified to be a deficiency in some cup wash units. That is, the steel tube, which empties the cup during the cup wash process, is too long causing it to touch the bottom of the cup. In this situation an un-bound tracer-analyte complex can bind to the tube and carry-over into subsequent tests. The countermeasure, which reduces the length of the steel tube by 0.4mm to ensure that there is a clearance between the tube and the bottom of the cup.
Remedy Action:	Replace the cup wash unit in each AQT90 FLEX analyzer
Athorized Representative/Importer/Distributor:	Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:	NCMDR
Source Ref. Number:	92BBB192422D2
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Radiometer Medical (2).pdf

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