SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

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

View History