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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 022 06 18 000
Date submitted: 6/7/2018
Manufacturer:Siemens Healthcare Diagnostics GmbH
Device Type:Dimension Integrated Chemistry Systems…
Description:IVDs, In vitro diagnostic devices
Medical Device Identifier:Dimension® EXL 200 : 10636928 / Dimension® EXL with LM: 10472176 / Dimension® RxL Max: 10444828 / Dimension® RxL Max HM: 10444829 / Dimension® RxL Max HM STM: 10444831 / Dimension® Xpand® Plus: 10444837 / Dimension® Xpand® Plus HM: 10444838 / Dimension® Rx.
This letter applies to Dimension systems listed in attachment running software version 10.2.2
Reason of Field Safety Corrective Action:The purpose of this communication is to inform you of intermittent failures with the group calibration feature in Dimension® Software Version 10.2.2. A calibration may not auto accept when performing a group calibration with more than one Quality Control (QC) product. If all QC levels are not processed, Dimension QCC PowerPak® auto acceptance for that calibration will not complete.
Remedy Action:A new Dimension Software Version is currently in development that will address this issue. Until the revised software is available and installed on your instrument, please continue to use the following instructions, as appropriate. Either of two approaches may be used:
QC levels that are not processed may be completed manually
Calibrations can be initiated manually by ordering via the Calibration setup screen and entering calibrator information.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:0EC0144B7119E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics Inc..pdf