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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 075 10 15 000
Date submitted: 10/21/2015
Manufacturer:Beckman Coulter
Device Type:UniCel DxH Slidemaker Stainer COULTER Cellular Analysis Systems
Description:IVD, Analyzer
Medical Device Identifier:Part Number 775222
Reason of Field Safety Corrective Action:Beckman Coulter has confirmed a possible mislabeling of the product name on the front panel of the Sample Transport Module (STM) on some DxH Slidemaker Stainer Coulter Cellular Analysis Systems.
Remedy Action:Inspect the label on your DxH Slidemaker Stainer system as shown in attachment. If the system is mislabeled, contact Beckman Coulter for the label to be corrected.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:5EA92B5A95221
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Beckman Coulter-3.pdf