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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 065 09 18 000
Date submitted: 9/18/2018
Device Type:i-STAT 1 Wireless Analyzers and i-STAT Alinity Instruments
Description:Analyzers, Laboratory, Clinical Chemistry
Medical Device Identifier:Product: Blood Analyzers

Abbott Point of Care Model : i-STAT Wireless (300W)
List Number: 03P75-XX

Abbott Point of Care Model : i-STAT Alinity Insturments
List Number: Not Listed.
Reason of Field Safety Corrective Action:May Be Susceptible to a KRACK Attack When Using Wi-Fi Protected Access Wireless Authentication Protocols
Remedy Action:Identify any affected analyzers in your inventory. If you have affected analyzers, verify that you have received the May 2018 Important Product Information letter from Abbott. If necessary, use an alternate wireless authentication mode and apply KRACK patches to your network infrastructure. Abbott will release updates to address the KRACK vulnerability.

Abbott Point of Care recommends that to mitigate the Key Reinstallation Attack (KRACK):
• Customers should update their organization’s network infrastructure (such as wireless access points, network controllers, etc.).
• Customers should update any affected devices that connect wirelessly to the network.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:B84F441C0B172
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf