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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 017 03 15 000
Date submitted: 3/4/2015
Manufacturer:Abbott
Device Type:ARCHITECT Anti-HBc II Reagent Kit
Description:IVD
Medical Device Identifier:List Number : 8L44-25 Lot Number : 42072LI00 Expiration Date 28-May-2015

List Number : 8L44-25 Lot Number : 42072LI01 Expiration Date : 28-May-2015

List Number : 8L44-25 Lot Number : 42253LI00 Expiration Date : 30-Jun-2015

List Number : 8L44-25 Lot Number : 42253LI01 Expiration Date : 30-Jun-2015

List Number : 8L44-30 Lot Number : 42255LI00 Expiration Date : 30-Jun-2015

List Number : 8L44-30 Lot Number : 42255LI01 Expiration Date : 30-Jun-2015

List Number : 8L44-35 Lot Number : 42256LI00 Expiration Date : 30-Jun-2015
Reason of Field Safety Corrective Action:The ARCHITECT Anti-HBc II assay shows lower calibrator, control and sample RLU values, potentially leading to reduced specificity and increased false reactive results.
Remedy Action:- Discontinue use of the lots listed above and destroy any remaining inventory of these lots according to your laboratory procedures.

- In the event you are currently using or have inventory of one of the lots listed above, immediately contact Customer Support for replacement material.

- Abbott recommends discussing the content of this letter with your laboratory management and communicating this information to the health care providers you serve to determine if any further testing is needed.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division
Report Source:NCMDR
Source Ref. Number:BBC6BDF941378
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf