FDAFebruary 7, 2024device

DCA Systems HbA1c Reagent Kit

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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%.

What to do

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414532806

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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