DCA Systems HbA1c Reagent Kit
FDA Recall #Z-1304-2024 — Class II — February 7, 2024
Product Description
DCA Systems HbA1c Reagent Kit
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%.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
Distribution
Worldwide distribution - US Nationwide and the country of Taiwan.
Code Information
Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot#: 9640093, 0645103, 0648103, 0649103, 0654103 . Expanded Lots (02/28/2024): 0637093, 0641093, 0642093, 0647103, 0653103, 0655103;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated