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Siemens Healthcare Diagnostics, Inc. recalls DCA Systems HbA1c Reagent Kit
Recalled March 27, 2024 · FDA recall Z-1304-2024 · Siemens Healthcare Diagnostics
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%. · FDA Class II
Units
74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
Sold at
Worldwide distribution - US Nationwide and the country of Taiwan.
Description
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%.
Product
DCA Systems HbA1c Reagent Kit
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →