Medical Device Recall: DCA Systems HbA1c Reagent Kit
Siemens Healthcare Diagnostics, Inc. · February 7, 2024
Reason for Recall
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%.
Distribution
Worldwide distribution - US Nationwide and the country of Taiwan.
States Affected
NATIONWIDE
Quantity Affected
74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1304-2024
Status: ongoing
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