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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 114 12 17 000
Date submitted:	12/26/2017

Manufacturer:	Beckman Coulter
Device Type:	DuraClone B27 Reagent Kit
Description:	IVD, Reagent
Medical Device Identifier:	REF No. : B36862 Multiple LOT numbers are provided in the attached FSN.
Reason of Field Safety Corrective Action:	Beckman Coulter has determined that the DuraClone B27 reagent lot number listed above have a defect that may generate false negative results in some samples.
Remedy Action:	• You can continue to use remaining inventory of lot numbers 050917, 070417_11, 090517, 120617_02, 170417_09, 170417_11, 190617 and 240717 with the new determinant and indeterminant zone values provided along with this letter. • Discard any remaining inventory of any other lots not listed in the Action first bullet point. Follow your local regulatory requirements for proper disposal. Please contact your local Beckman Coulter representative for replacement product. • Consult your medical director of the laboratory to determine the need for retrospective review of test results and possible re-testing. • If you have already generated and reported results using lot numbers: 050917, 070417_11, 090517, 120617_02, 170417_09, 170417_11, 190617 or 240717, it is recommended that the sample typing be re-determined for all the samples that had MFI values between 10 to 19 when tested on Navios/Cytomics FC 500 cytometers and channel values between 517 to 602 when tested on BD FACSCalibur/ BD FACScan cytometers, using the new determinant values provided in the letter. • If you have already generated and reported results using lot numbers other than those mentioned in the Action first bullet, it is recommended to verify the HLA B27 results for all the samples that have MFI between 10 to 19 using Navios/Cytomics FC 500 and channel values between 517 to 602 using BD FACSCalibur/ BD FACScan using alternate methods such as PCR.
Athorized Representative/Importer/Distributor:	Al-Jeel Medical & Trading Co. LTD
Report Source:	NCMDR
Source Ref. Number:	B1BF02DB922DF
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Beckman Coulter.pdf

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