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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 052 05 15 000
Date submitted: 5/11/2015
Manufacturer:Abbott
Device Type:Sekisui Diagnostics Acetaminophen Reagent
Description:IVD, Acetaminophen assay
Medical Device Identifier:Catalog/List Number (LN) : 2K99-20
Lot Numbers : 45797UQ04, 46121UQ07, 46561UQ08, 46207UQ09, 46953UQ12
Reason of Field Safety Corrective Action:The interference for N‐acetylcysteine (NAC) has increased (resulting in a larger negative bias in Acetaminophen concentration), relative to the level reported in the reagent package insert.
Remedy Action:1. Effective immediately, this communication will serve as temporary labeling for the updated interference level of the assay in the presence of N‐acetylcysteine (NAC).

2. Please follow your internal procedures for notifying healthcare providers of this change to the interference level.

3. Please follow your laboratory protocol regarding the need for reviewing previously reported patient results.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division
Report Source:NCMDR
Source Ref. Number:D96E7A89972E1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Diagnostics.pdf