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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 015 01 13 000
Date submitted: 1/5/2013
Manufacturer:Abbott Diagnostic International Ltd
Device Type:Reagent Controls and Calibrators, ARCHITECT
Description:Reagent Controls and Calibrators
Medical Device Identifier: List Number: (1) 7K73-20 (2) 7K73-25 (3) 7K73-01 (4) 7K73-10 Serial/Lot Number (1) 11907JN01, 13909JN01, 15909JN01, 15916JN00, 18907JN01, 18907JN02, 21901JN01 (2) 11907JN00, 13909JN00, 15909JN00, 15916JN01, 18907JN00, 21901JN00, 21901JN03, 21901JN04 (3) 17342JN00, 19142JN00, 19142JN01, 19142JN02, 22270JN00, 23277JN00, 23277JN01 (4) 17203JN00, 19075JN00, 22121JN00, 23199JN00
Reason of Field Safety Corrective Action: The purpose of this letter is to communicate a field correction regarding the product labeling for safety precautions associated with the ARCHITECT Testosterone assay. The current labels and package inserts for the ARCHITECT Testosterone Reagent, LN 7K73- 20 and 7K73-25, ARCHITECT Testosterone Calibrators, LN 7K73-01 and ARCHITECT Testosterone Controls, LN 7K73-10 do not contain the warnings and precautions applicable to material containing methylisothiazolones which are classified as skin sensitizers.
Remedy Action: Treat this product as a ‘skin sensitizer’. The following hazard symbol (See attached) applies to all ARCHITECT Testosterone product labeling.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:EEA5FD6BA83A3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Diagnostic International Ltd.pdf