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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 077 10 15 001
Date submitted:	12/8/2016

Manufacturer:	Beckman Coulter
Device Type:	COULTER Body Fluid Control Level 1
Description:	Blood Cell Counter
Medical Device Identifier:	COULTER Body Fluid Control Kit PN 628030, Level 1 ........................ NCMDR update codes : Kit: 4511690K Control: 183231620 Kit: 4511700K Control: 183231630 Kit: 4511710K Control: 183231630 Kit: 4511720K Control: 183231630 Kit: 4511730K Control: 183231630 Kit: 4511740K Control: 183231640 Kit: 4511750K Control: 183231650 Kit: 4511760K Control: 183231660 Kit: 4511770K Control: 183231660
Reason of Field Safety Corrective Action:	Beckman Coulter has conftrmed high and/or out-of-range values for TNC on Control Level 1, for the kits and vials listed in the table at the end of this notice, when compared to the published table of expected results.
Remedy Action:	-If your Body Fluid Control Level 1 does not recover within the values in the Table of Expected Results, establish your own mean value according to the Instructions for Use, REF A59932-AD. -Apply the Beckman Coulter Expected Range to your mean value
Athorized Representative/Importer/Distributor:	Al-Jeel Medical & Trading Co. LTD
Report Source:	NCMDR
Source Ref. Number:	24E9CA6D51295
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Beckman Coulter.pdf

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