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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 034 12 18 000
Date submitted: 12/11/2018
Manufacturer:Siemens Healthcare Diagnostics GmbH
Device Type:ADVIA Centaur Anti-Thyroglobulin (aTG) Positive Bias, ADVIA Centaur, XP, XPT and CP
Description:IVDs
Medical Device Identifier:ADVIA Centaur
aTG (100 test
kit) : 10492398
Lots: 68748302 68749302 83577304 88637304 05610306 96436306 19097308 31866310 45386310 55627312 69208316 73000316

ADVIA Centaur
aTG (500 test
kit : 10492399
Lots: 68750302 68751302 83578304 91382304 04642306 08116306 19098308 22635308 33640310 39133310 55625312 55626312 56285312 69206316 73001316
Reason of Field Safety Corrective Action:Siemens identified a positive bias with ADVIA Centaur aTG kit lots ending in 316 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
Remedy Action:You may continue use of ADVIA Centaur aTG kit lots in Table 1 until you receive replacement product in your laboratory. If you are currently using ADVIA Centaur aTG kit lots in Table 1, review your inventory of these products as well as the associated Calibrator 1, aTG QC and aTG Master Curve Material and order replacement products by completing the Field Correction Effectiveness Check Form attached to this letter.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:143F91CCFB2AB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics Inc..pdf