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 115 07 17 000
Date submitted:	7/26/2017

Manufacturer:	Randox Laboratories Ltd.
Device Type:	Liquid Urine Control Level 3
Description:	In vitro diagnostic devices
Medical Device Identifier:	Catalogue Number: UC5075 GTIN : 05055273207576 Batch / Lot number: 907UC Expiry Date: 28-06-2019 Manufacturing Date: 13-12-2016
Reason of Field Safety Corrective Action:	Randox has identified a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. The correct values should be as detailed in the table (See Attached FSN).
Remedy Action:	•Value sheet has been updated and should be placed into any remaining stock. •Discuss the contents of this notice with your Medical Director.
Athorized Representative/Importer/Distributor:	Bio Standards
Report Source:	NCMDR
Source Ref. Number:	015D6C4A0611A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Randox Laboratories.pdf

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