FDA Device recall Z-1304-2024
DCA Systems HbA1c Reagent Kit
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of DCA Systems HbA1c Reagent Kit by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1304-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-07 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
DCA Systems HbA1c Reagent Kit
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%.
Identifiers
| code_info | Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot#: 9640093, 0645103, 0648103, 0649103, 0654103 . Expanded…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2024%22
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