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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 096 11 12 000
Date submitted: 11/24/2012
Manufacturer:Olerup SSP AB
Device Type:IVD, Human leukocyte antigen typing kit
Description:In vitro diagnostic devices, leukocyte, Kit
Medical Device Identifier:Model: 101.221-12 HLA-typing kit DQB1-High, lot 10M and 85N
Reason of Field Safety Corrective Action:DQBl*03:05:02 and DQBl*03:05:04 can possibly give wrong result due to the false negative in primermix 11. DQBl*03:05:01 and DQBl*03:05:03 reacts as they should.
Remedy Action:manufacturer has updated the product information with the information that the DQB1 *03:05:02 and 03:05:04 alleles are not amplified by primermix 11. The manufacturer has issued a FSN. Information is sent direct to customers and to distributors. Distributors should in term inform their customers of these lots. The customers should check whether they used these lot numbers and if so use the revised documents for re-evaluation of patient DNA, as well as for future DNA analysis with kits from these lots. The manufacturer has repacked all products in stock with the revised information.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:SE-2012-11-16-039
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments