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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 033 12 18 000
Date submitted: 12/11/2018
Manufacturer:Abbott
Device Type:CP3000 w/ CTS and w/o CTS 230V
Description:Automated coagulation testing system for reference and core laboratories
Medical Device Identifier:CP3000 w/ CTS 230V
02R73‐02
Lots : CP3490245, CP3490246, CP3490254, CP3490322, CP3490323, CP3490369, CP3490370, CP3490396, CP3490397, CP3490398, CP3490399, CP3490400, CP3490401
CP3000 w/o CTS 230V
02R74‐02
Lot : CP3480243
Reason of Field Safety Corrective Action:Abbott Diagnostics has received the attached letter from Sekisui Medical CO., LTD, the manufacturer of the CP3000 System. Sekisui has identified an issue with the current software V1.11 and below on the CP3000 System that could potentially impact patient results and usability. In addition, the letter from Sekisui includes precautions when using the bottle changeover function with a new lot of reagent if the instructions in the User Manual are not followed.
Remedy Action:The attached letter from Sekisui Medical provides information on immediate actions to be taken when using Becton Dickinson Vacutainer 1.8mL blood collection tubes. Additionally, the Sekisui Customer Notification also includes clarification to the instructions in chapter 6.6.2.2 of the CP3000 User Manual (version UME‐CP3K‐R400) when loading more than one lot number of the same reagent onto the reagent carousel and immediate actions to be taken should the instructions not be followed.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:BA9AC672E036C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf