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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 056 07 18 000
Date submitted: 7/10/2018
Manufacturer:Abbott Laboratories Inc
Device Type:Alinity s System
Medical Device Identifier:List Number (LN) : 06P16‐01
Reason of Field Safety Corrective Action:During in‐house Alinity s System assay testing, Abbott identified the possibility of unexpected low RLU (Relative Light Units) values on sample results for all Alinity s assays.
Remedy Action:Until the permanent solution is implemented, you must perform the following actions to mitigate potential impact. The review of sample RLU values applies to ongoing operations as well as all previously generated results, in the event they may not all have been transmitted to AbbottLink.
The RLU results may be viewed using the methods in attachment file.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:57F6C4563429B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott GmbH.pdf