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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 119 05 18 000
Date submitted: 5/24/2018
Manufacturer:Randox Laboratories Ltd.
Device Type:Liquid Assayed Specific Protein Controls
Description:In vitro diagnostic devices
Medical Device Identifier:Catalogue Numbers: PS2682, PS2683,PS2684
Reason of Field Safety Corrective Action:Randaox has confirmed that Free Kappa light chains in their Liquid Assayed Specific Protein Controls increase over shelf life of the product
Remedy Action:- Discuss the content of this notice with the Medical Director
- Place a copy of important notice and updated IFU into any remaining stock
- Complete and return the vigilance response section of this form.
Athorized Representative/Importer/Distributor:Bio Standards
Report Source:NCMDR
Source Ref. Number:2A52B6692F1CA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Randox Laboratories Ltd..pdf