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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 080 08 17 000
Date submitted:	8/21/2017

Manufacturer:	Randox Laboratories Ltd
Device Type:	Immunoassay Premium and Premium Plus Quality Controls
Description:	In vitro diagnostic devices
Medical Device Identifier:	Immunoassay Premium Plus Quality Controls Catalogue Number : GTIN IA3109 : 05055273207255 IA3110 : 05055273207262 IA3111 : 05055273207279 IA3112 : 05055273207286 Immunoassay Premium Quality Controls Catalogue Number : GTIN IA2638 : 05055273203844 IA2639 : 05055273203851 IA2640 : 05055273203868 IA2633 : 05055273203837
Reason of Field Safety Corrective Action:	Randox has confirmed that ACTH in our Immunoassay Premium Plus quality control and Immunoassay Premium quality control does not meet the quoted reconstituted stability claim in the product IFU. We now recommend that ACTH is to be assayed immediately after the 30-minute reconstitution procedure.
Remedy Action:	Place a copy of the important notice in all kits remaining in stock. A review of previous results is not necessary as recovery outside control ranges is evident at the time of testing.
Athorized Representative/Importer/Distributor:	Alinfrad Trading Est.
Report Source:	NCMDR
Source Ref. Number:	F4F94113972D8
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Randox Laboratories Ltd 2.pdf

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