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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 048 06 17 000
Date submitted: 6/11/2017
Manufacturer:Abbott Laboratories Inc
Device Type:MULTIGENT Creatinine (Enzymatic)
Description:List number : 8L24-31
Medical Device Identifier:List number : 8L24-31
Lot Number : 60335Y600, 60382Y600
UDI Number : (01)00380740017682(17)180228, (10)60335Y600(240)8L2431, (01)00380740017682(17)180228, (10)60382Y600(240)8L2431

List Number : 8L24-41
Lot Number : 60334Y600
UDI number : 01)00380740017699(17)180228, (10)60334Y600(240)8L2441
Reason of Field Safety Corrective Action:Abbott received the attached letter from Sentinel, the manufacturer of the MULTIGENT Creatinine (Enzymatic) reagent. Sentinel have confirmed a performance issue with the three lots listed above which may result in Quality Control values shifting out of acceptable ranges or erratic patient results.
Remedy Action:Please review carefully and follow the instructions. Contact Abbott Customer Service for assistance if needed.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:AD2F5C9F8D264
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf