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 063 07 17 000
Date submitted: 7/17/2017
Manufacturer:Bio-Rad Medical Diagnostics
Device Type:ID-Papain
Description:Immunohematology, ID-Papain
Medical Device Identifier:Double population reaction Mat. n° : 005510

Loss of enzyme activity Mat. n° : 005510

Lot No IHD : 06311 961, 06311 97 1, 06311 991, 06311 02 1

Lot No SAP : 121302961, 124782971, 141517991, 145832021

Expiry Date : 03.07.2017, 17.07.2017, 31.07.2017, 14.08.2017
Reason of Field Safety Corrective Action:It has come to our notice that for product ID-Papain, Mal n° 005510, shows double population reactions when the auto-control is performed in papain one stage technique.
It has been observed internally that in the last two weeks before expiry, the lots of papain mentioned above may not destroy these antigens as expected. There is no patient risk associated with this issue. The use of ID-Papain for compatibility testing and for the detection of antigens normally detected in the ID-Papain test is not impacted by this phenomenon and the papain can be used for this purpose.
Remedy Action:-If the test gives unexpected positives and/ or double population reactions in the one-step technique, use preferentially the two stage method.
-Use the most recent lot available in your stock.
-Use an alternative method (replace the ID-papain by one stage ID-Diluent 1)
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:9E9A26B417229
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Bio-Rad Laboratories.pdf