X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 058 05 18 000
Date submitted: 5/13/2018
Manufacturer:Siemens Healthcare Diagnostics
Device Type:ADVIA Centaur®, ADVIA Centaur®XP, ADVIA Centaur®XPT, and ADVIA Centaur®CP
Description:IVDs, clinical chemistry instrumentation
Medical Device Identifier:Assay: Procalcitonin
Siemens Material Number (SMN): 10378883
Lot Numbers: 97643038, 10719038, 14888038, 37183047, 37184047, 45947047
Reason of Field Safety Corrective Action:Siemens Healthcare Diagnostics has received multiple customer complaints for invalid calibrations with ADVIA Centaur Systems BRAHMS Procalcitonin reagent kits listed above. This issue affects the ADVIA Centaur/XP/XPT and ADVIA Centaur CP systems.
Remedy Action:• Customers may continue to report procalcitonin patient results when a valid calibration and in range quality control results are obtained with any kit lot of ADVIA Centaur Systems BRAHMS PCT.
•For the products listed in above , please perform the following steps: -If you experience calibration failures and are unable to obtain valid calibration with ADVIA Centaur Systems BRAHMS PCT kit lots ending in 038 and 047, customers are invited to request unaffected product from their local Siemens/distributor office.
-To receive replacement kits for affected product, please complete and return the provided form.

Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:199541B9131BB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics.pdf