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Siemens Response Re PTT Control Drift

From Siemens Manager Carol Shearer:

To help you with your quandary….It looks like Tara really followed our process. What is recommended by Siemens is for the customer to contact Siemens to file a complaint about the reagent or control. We log and file all calls and tally the number of calls by lot number of reagent or control. If there have been no or few calls, we recommend that they adjust the range and we may have them send product into us for testing against non-shipped product. Once testing is complete, a letter of the results is sent to the customer. If we have a documented issue, then we send a letter and replace any product that they have in-house. We do extensive quality testing as products are produced. Siemens  stands behind our products and will replace as necessary.
Tara’s question as to what independent resource is available, I would say the proficiency testing that they participate in would be considered independent. However, she should not want to use this alone and fail. That is why our LabLink QAP program is used so that customers can see when there is a change in their testing system and investigate before their proficiency samples arrive. Tara does not state whether she participates in the LabLink QAP program, but I highly recommend it. She could review the data to see how her lab, using her instrument, and her reagents and controls compares to others using the same set up. The only difference between her and the other participants could be her reagent lot number. The control lot number would be the same.

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