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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 121 02 13 000
Date submitted: 2/17/2013
Manufacturer:Thermo Fisher Scientific
Device Type:IVDs, MULTIGENT® Benzodiazepines Assay
Description:IVDs, MULTIGENT Benzodiazepines reagent
Medical Device Identifier:List Number 3L39-20 Lot Number: 13434M500, EXP. Date: 31 May 2013 Lot Number: 16082M500, EXP. Date: 31 Oct 2013 Lot Number: 20167M500 EXP. Date: 31 Jan 2014 Lot Number: 22147M500 EXP. Date: 31 Mar 2014
Reason of Field Safety Corrective Action:an increase in the recovery of Bio-Rad Quality Control (QC) containing Lormetazepam when used with MULTIGENT Benzodiazepines lot 13434M500. Polyclonal antibody based immunoassays that measure class compounds such as benzodiazepines will exhibit lot to lot variation with regards to sensitivity to various compounds within the class
Remedy Action:Evaluate your QC ranges per your laboratory’s procedures. Alternatively, you may use MULTIGENT DOA MC I Control Set, List Number 3L43-10, which contains Oxazepam instead of Lormetazepam and is validated for use with the MULTIGENT Benzodiazepines assay.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555
Report Source:NCMDR
Source Ref. Number:96BDB1F160355
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Thermo Fisher Scientific.pdf