OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 072 08 18 000
Date submitted: 8/18/2018
Manufacturer:Roche Diagnostics GmbH
Device Type:FLO LOK III Dispenser
Medical Device Identifier: - Please check attachment for codes -
Reason of Field Safety Corrective Action:In December 2017, Roche Tissue Diagnostics (RTD) issued a Field Safety Notification (FSN) in response to escalated complaints of leaking and sticking reagent dispensers. Roche initially attributed this failure to inadequate application of silicone oil to critical parts in the Horseradish Peroxidase (HRP) and Hematoxylin II dispensers. At that time, Roche initiated a root cause investigation.
Remedy Action:Customers should first determine if their laboratory has any affected product lots in inventory based on the "Expanded Affected Lots" column present in this notification. If an affected product is found, it should not be used for clinical testing. In addition, should you have any remaining dispensers from lots listed in the "Previously Communicated Lots" column, you must not use them for clinical testing. The initial FSN required the use of same slide controls if affected product was to be used. This is because we did not have sufficient inventory of replacement product at that time. Newly manufactured products from the affected list are now readily available and should be used in place of affected product lots.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:DA21F21F3F24B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche.pdf