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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 007 02 17 000
Date submitted: 2/2/2017
Manufacturer:Bio Rad.
Device Type:Platelia™ Aspergillus Ag assay
Description:In vitro diagnostic device
Medical Device Identifier:Platelia™ Aspergillus Ag assay-Ref. 62794/Evolis™ System-Ref.89601
Reason of Field Safety Corrective Action:Some laboratories performing the assay using an automated method on Evolis™ Sytem informed us recently that they were facing some issues when validating the OD R4(Cut-off Control Serum) criteria. For some runs, the OD R4 value being <0.600, the current OD R4 validation criteria (0.600≤ OD R4 ≤ 1.800) were not met and the calculation of sample index was impossible.(See attached FSN)
Remedy Action:A “patch” (Evolis™ Aspergillus Patch CD Ref. 93486) containing the new Evolis™ APF will be used for implementing the new validation criteria in laboratories performing the assay on Evolis™ System. After contacting your Bio-Rad’s Customer Technical Support, the new Evolis™ APF will be installed as soon as possible and at your convenience by remote control (equipped laboratories) or by a Bio-Rad FSE visiting your laboratory.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:9FEE98B7EB3C7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BioRad.pdf