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MDA/2008/056 - Laboratory analysers and their associated assays - ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, manufactured by Siemens Healthcare Diagnostics, serial numbers 078-A001-XX and XP 078-A010-XX

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/056
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 24 July 2008 at 13:45
Ref: MDA/2008/056

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Laboratory analysers and their associated assays – ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, manufactured by Siemens Healthcare Diagnostics, serial numbers 078-A001-XX and XP 078-A010-XX.		  
Problem:
Failure to detect a low level of wash 1 fluid. This may lead to erroneous test results in high risk biomarkers (Appendix 1 - in pdf only).

>Page 2

Action by:
Laboratory staff using this device.		  

Action:

1. Follow the manufacturer’s instructions in the Field Safety Notice (Appendix 2 - in pdf only).

    • Ensure procedures are in place to regularly check the fluid level on the wash 1 bottle. Frequency of checks will depend on usage.
    • Be vigilant for trends of positive (elevated) or negative (depressed) results that would alert the user to a problem. If a trend towards positive or negative results is seen, check the level of fluid in the wash 1 bottle and run quality control samples

2. Consider the need for clinical review of previous patient results that may have been affected by this problem.
3. Ensure that you have appropriate systems in place for any relevant follow-up testing (e.g. confirmation of results).

  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI)) - Headquarters
NHS Boards in Scotland  - Chief Executives
Health Protection Agency (HPA) - Directors*

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer/supplier contacts and contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 2

Appendix:
Appendix 1: Clinical risk assessment of assays affected by wash 1 depletion (in pdf only).
Appendix 2: Manufacturer Field Safety Notice issued in March 2008 (in pdf only).

>Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 31 July 2008
Deadline (action complete): 13 August 2008


Page last modified: 24 July 2008