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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 056 07 18 000
Abbott Laboratories Inc
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.
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.
Medical supplies & Services Co.Ltd Mediserv
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.