DCA Systems HbA1c Reagent Kit
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
Worldwide distribution - US Nationwide and the country of Taiwan.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1304-2024