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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 052 09 14 000
Date submitted:	9/17/2014

Manufacturer:	Abbott
Device Type:	ARCHITECT Total T3 Reagent Kit
Description:	IVD Test Reagent/Kits, Immunoassay
Medical Device Identifier:	Lot Numbers : 38901UI00, 38901UI01 Expiry 29 January 2015
Reason of Field Safety Corrective Action:	Abbott determined that 17% of the two reagent lots listed in this FSN may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.
Remedy Action:	- Discontinue use of and destroy any remaining inventory according to your laboratory procedures. - Follow your laboratory protocol regarding the need for review of previously reported patient results. - Replacement material is available. For ordering, please order through your normal ordering process.
Athorized Representative/Importer/Distributor:	Abbott Diagnostics Division, Jeddah, (012) 6511077
Report Source:	NCMDR
Source Ref. Number:	866F6D834522A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Abbott Diagnostics.pdf

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