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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 027 04 17 000
Date submitted: 4/9/2017
Manufacturer:Bio Rad
Device Type:Monolisa HCV
Description:Reagents, Serology, Virus
Medical Device Identifier:Code numbers: 72561, 72562
Multple Lot numbers of the affected device are provided in the attached FSN.
Reason of Field Safety Corrective Action:There is a decrease of all optical densities when using the above listed kits due to stability issue of R6 reagent.
Remedy Action:• To continue to use kits and affected lots as long as the validation criteria are met (refer to product package insert (section 7.5) for detaied instructions):
1)For the negative control R3: O.D. < cut off x 0.6
2)For the antibodies positive control R4: 0.800 ≤ Mean O.D. ≤ 2.700
3)For the working solution R5: O.D. > 0.500
•To stop using kits of affected lots if validation criteria failed. In that case, discard the kit, fill the Annex 1 and return it to your customer service to obtain replacement kits.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:78DC786B6B2A2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Bio-Rad.pdf