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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 124 12 15 000
Date submitted: 12/29/2015
Manufacturer:Beckman Coulter
Device Type:COULTER S-CAL Calibrator Kits
Description:Cellular Analysis Systems
Medical Device Identifier:REF # 624519, 179310 and 628026

KIT/VIAL LOT NUMBERS: See attached table for kit and vial lot numbers
Reason of Field Safety Corrective Action:Customers have reported a variety of issues during calibration including:

- An increase in H&H Check messages - Low MCH recovery in XB - Low MCHC recovery in XB

These issues are not observed with all analyzers.
Remedy Action:-Continue to monitor other quality control performance and adhere to your established maintenance schedule.

-For laboratories who reported issues after calibration with the affected lots, recalibration with S-CAL vial lots beginning with 4782 or 113160400 or beyond is suggested.

-For product replacement, please fill out and return the Replacement Order form included with this notice or contact your local Customer Service Support.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:2196FEA8462A3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Beckman Coulter.pdf