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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 125 07 18 000
Date submitted: 7/24/2018
Device Type:ARCHITECT Creatine Kinase
Medical Device Identifier:List Number : 7D63‐21
Lot Number : 87697UN18, 99632UN18, 24358UN18,

List Number : 7D63‐41
Lot Number : 99633UN18
Reason of Field Safety Corrective Action:The purpose of this letter is to inform you of a product recall for the ARCHITECT Creatine Kinase (CK) reagent lot numbers listed above and to provide instructions on what actions your laboratory must take.
Abbott has identified a stability issue that may lead to the following issues: Error Code 1054 “Unable to calculate result, reaction check failure” Quality Control (QC) results out of range low
Remedy Action:If you have an alternate reagent lot available in inventory THEN Immediately discontinue use of the reagent lot number(s) listed above and switch to the alternate reagent lot. Destroy any remaining inventory of impacted material according to your laboratory procedures.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:9CE9D59946339
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott 2.pdf