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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 129 04 18 000
Date submitted: 4/26/2018
Manufacturer:Siemens Healthcare Diagnostics
Device Type:Dimension clinical chemistry system and Dimension Vista System Gentamicin (GENT) Flex reagent cartridge
Description:IVD Test Reagent/Kits, Clinical Chemistry
Medical Device Identifier:1) Catalog Number: DF12 Siemens Material Number: 10444927 Lot Number: EB8115 Exp: 2018-04-25, Lot Number: BB8159 Exp: 2018-06-08 Lot Number: FB8275 Exp: 2018-10-02

2) Catalog Number: K4012 Siemens Material Number: 10445120 Lot Number: 17135BC Exp: 2018-05-15 Lot : 17150BF Exp: 2018-05-30, Lot Number: 17159BD Exp: 2018-06-08, Lot Number: 17178AC Exp: 2018-06-27, Lot Number: 17269BD Exp: 2018-09-26, Lot Number: 17312BB Exp: 2018-11-08
Reason of Field Safety Corrective Action:Potential Inaccuracy at the low end of the Analytical Measurement Range
Remedy Action:- Inspect stock, discontinue use of and discard the Dimension and Dimension Vista GENT affected lots
- Please review this letter with your Medical Director.
- Review your inventory of these products to determine your laboratory’s replacement needs and to provide information to Siemens for reporting to the regulatory authorities.
- Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.
- If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:FC52CBDAC63B9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics.pdf