Customer Bulletin 2019-11, Rev B

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CUST-00527-EDG Rev B

Customer Bulletin

2019-11, Rev B

DCA Vantage Analyzer

DCA Vantage Analyzer Calibration Update

This communication applies to the following products:

SMN Product Name

10698915 DCA

HbA1c test kits with diagnostic claim 10888639 DCA

HbA1c test kits with self-test claim

As part of our ongoing commitment to continuously improve our products, Siemens Healthineers closely monitors performance of the DCA HbA1c test kits’ performance on external proficiency schemes. In recent months, a negative bias has been observed on several schemes globally.

To that end, we are further optimizing our calibration processes and are targeting to

implement an update in November 2019. As a result of this change, customers may observe a minor positive shift in results.

All manufactured lots have met and continue to meet our existing product claims. This calibration adjustment will not impact the testing procedure or the instructions for generating test results.

The adjustment will be implemented in DCA HbA1c diagnostic claim kits (SMN 10698915) in November 2019 with lot 0594119. Self-test kits (SMN 10888639) will be implemented in December 2019.

Please note that the last three digits of the lot number listed on DCA HbA1c test kit boxes indicate the date of manufacture as shown below:

For example, lots produced in December 2019 follow the convention XXXX129.

DCA Vantage Analyzer Calibration Update—DCA HbA1c Test Kits

CUST-00527-EDG Rev B Page 2 of 2

Based on internal testing, the expected differences that may be observed with patient, QC, and proficiency sample results at various levels are shown below:

Reporting Units HbA

Level Expected Increase in Test Results

%HbA

5.0% HbA

~0.1 %HbA

6.5% HbA

~0.2 %HbA

8.0% HbA

~0.25 %HbA

10.0% HbA

~0.3 %HbA

mmol/mol

30 mmol/mol ~1.3 mmol/mol 48 mmol/mol ~2.0 mmol/mol 64 mmol/mol ~2.7 mmol/mol 86 mmol/mol ~3.5 mmol/mol

If you have any further questions, please contact your local Siemens representative.

DCA and DCA Vantage are registered trademarks of Siemens Healthcare Diagnostics.