Device product
DCA Systems HbA1c Reagent Kit
Z-1304-2024
Product summary
- Event
- Event 94021
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
- Official record key
device-enforcement:Z-1304-2024
Official wording
Reason: 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%.
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;
Distribution pattern: Worldwide distribution - US Nationwide and the country of Taiwan.
Derived failure modes
-
Unknown
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%.