SFDA National Center for Medical Devices Reporting

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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 056 10 18 001
Date submitted:	11/5/2018

Manufacturer:	Abbott
Device Type:	ARCHITECT Free T3 Reagent Kit, ARCHITECT Total T3 Reagent Kit v
Description:	IVD, Reagents, Immunoassay
Medical Device Identifier:	1) Product Name: ARCHITECT Free T3 Reagent Kit List numbers : 7K63-20, 7K63-25, 7K63-27 2) Product Name: ARCHITECT Total T3 Reagent Kit List Number: 7K64-20, 7K64-25, 7K64-27 Swissmedic Update Code: ARCHITECT Free T3 (FT3) assay Model: 7K63-30/35/32/37 Lot: All Architect Total T3 Reagent Kit Model: 7K64-30/35/32/37 Lot: All
Reason of Field Safety Corrective Action:	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to reagent carryover when testing on board with the assays specified in table 1 (See attached FSN) .
Remedy Action:	Check the instructions in the attached FSN.
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv
Report Source:	NCMDR , Swissmedic
Source Ref. Number:	5F005ABF501C8 , Vk_20181016_06
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	(Vk_20181016_06 ) Abbott.pdf

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