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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 056 10 18 001
Date submitted: 11/5/2018
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