X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 092 07 18 000
Date submitted: 7/18/2018
Manufacturer:bioMerieux Inc
Device Type:VIDAS CA 15-3
Description:IVDs
Medical Device Identifier:VIDAS CA 15-3 (Ref. 30429) lots 1006022590 and 1006251930
Reason of Field Safety Corrective Action:Following customers’ complaints for calibrations out of range (Standard S1 out of range low and/or Control C1 out of range high) when using VIDAS CA 15-3 lots 1006022590 and 1006251930, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers.
Remedy Action:• Destroy the impacted lots: VIDAS CA 15-3 (Ref. 30429) lots 1006022590 and 1006251930.
• If you wish to be supplied with a replacement VIDAS CA15-3 kit, please call your bioMérieux local representative that will give your laboratory the appropriate support.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:947F55F7F9358
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BioMerioux.pdf