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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 068 07 18 000
Date submitted:	7/11/2018

Manufacturer:	Siemens Healthcare Diagnostics
Device Type:	Dimension Vista LOCI Reaction Vessels
Description:	IVD Test Reagent/Kits, Immunoassay
Medical Device Identifier:	Catalog Number: KS855 Siemens Material Number: 10445212 Lot Number: All lots prior to lot NH3912618 First Shipment Date: 2018-05-10
Reason of Field Safety Corrective Action:	Siemens Healthcare Diagnostics has received customer complaints regarding Dimension Vista® LOCI® Reaction Vessels causing Vessel Pickup errors. Supplier internal investigation has identified the potential for a LOCI Reaction vessel to contain a small hole or indent on the top of the vessel. This may result in the Vista system generating a “Vessel Pickup error” when the defective vessel is not successfully picked up by the vacuum system. The error is resolved when the defective vessel is removed from the system.
Remedy Action:	- Due to the low frequency of vessels causing errors, Siemens is recommending continued use of all lots. To identify the Dimension Vista LOCI Reaction Vessel lot number your laboratory is currently using; the last five (5) digits of the vessel lot number contain the manufacturing date: The first three (3) digits represent the Julian date with the last two (2) digits representing the year of manufacture. For example, lot NH3912618 126 = Manufacturing Julian date 18 = Manufacturing year 2018 Therefore, any Vista LOCI Reaction vessel lot number with a Julian date lower than 126 and manufactured in 2018 or earlier may be impacted. - If you should encounter a “Vessel Pickup error”, please refer to the Vista Operator’s Guide or online Vista iGuide (Chapter 8; Troubleshooting section) for guidance to clear the error. 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:	2A872C0F8D179
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Siemens Healthcare Diagnostics.pdf

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