Siemens ADVIA Centaur Safety Notes Download Page 4

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System Misinterprets Wash 1 Fluid Signals

In addition to the steps listed above, please perform the following:

•

Complete the Field Effectiveness Check attached to this letter.

•

Please retain this letter with your laboratory records, and forward this letter to those who
may have received this product.

We apologize for the inconvenience this situation has caused. If you have any questions, please
contact your Siemens Technical Solutions Center or your local Siemens technical support
representative.

ADVIA Centaur is a trademark of Siemens Healthcare Diagnostics.

Urgent Field Safety Notice 10813924, Rev. A – November 2012

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GPF-003-11 V1.0 Effective: September 21, 2012
Related Procedure: GP-003 DX- Field Correction Action

Summary of Contents for ADVIA Centaur

Page 1: ...eservoir is empty when it is actually full If the system fails to detect an empty Wash 1 bottle and reservoir it can continue to process samples and produce erroneous but believable results which are falsely high or low depending if the assay architecture is direct or indirect This issue potentially affects only those assays that use Wash 1 Table 1 Table 1 Assays Potentially Affected Assay Type As...

Page 2: ...age indicating that fluid is depleted and the system is going to stop sampling This case has no affect on results Actions to be Taken by the Customer Please use the actions below to address the following issues 1 The system fails to detect that the Wash 1 bottle and reservoir are empty and continues to process samples 2 The system stops processing samples even though there is sufficient Wash 1 pre...

Page 3: ...nterconnect PCB is malfunctioning or if there is another system problem Please call your local support representative to report the problem after attempting to clear the status or error message Clearing a Yellow Supplies Status Button a Lift the lid of the Wash 1 bottle b Close the lid of the Wash 1 bottle The system displays Did you refill the Wash 1 Bottle c Select Yes d Prime the Wash 1 fluid b...

Page 4: ...e who may have received this product We apologize for the inconvenience this situation has caused If you have any questions please contact your Siemens Technical Solutions Center or your local Siemens technical support representative ADVIA Centaur is a trademark of Siemens Healthcare Diagnostics Urgent Field Safety Notice 10813924 Rev A November 2012 Page 4 of 5 GPF 003 11 V1 0 Effective September...

Page 5: ... of the enclosed Siemens Healthcare Diagnostics Urgent Field Safety Notice dated November 2012 regarding System Misinterprets Wash 1 Fluid Signals 10813924 Please read each question and indicate the appropriate answer Fax this completed form to Siemens Healthcare Diagnostics at the fax number indicated at the bottom of this page I have read and understood the Urgent Field Safety Notice instruction...

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