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 035 12 18 000
Date submitted:	12/11/2018

Manufacturer:	Siemens Healthcare Diagnostics GmbH
Device Type:	Atellica IM Anti-Thyroglobulin (aTG) Positive Bias
Description:	IVDs
Medical Device Identifier:	Atellica IM aTG (100 test kit) : 10995461 Lots: 72259303 87903305 94908307 96439307 16824309 25822309 28942311 55978313 70389317 Atellica IM aTG (500 test kit) : 10995462 Lots: 56683313 70390317
Reason of Field Safety Corrective Action:	Siemens identified a positive bias with Atellica IM aTG kit lots ending in 317 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 Atellica IM aTG kit lots in Table 1 until you receive replacement product in your laboratory. If you are currently using Atellica IM 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 product 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:	36B3F062DC317
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Siemens Healthcare Diagnostics Inc. 2.pdf

View History