DCA Systems HbA1c Reagent Kit — Class II medical device recall Z-1304-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-03-27, distributed nationwide. The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias w
| Recall number | Z-1304-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2024-02-07 |
| Classified | 2024-03-19 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| UPC / GTIN / UDI-DI | 00630414532806 |
| Lot numbers | 0637093, 0641093, 0642093, 0645103, 0647103, 0648103, 0649103, 0653103, 0654103, 0655103, 9640093 |
Product
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%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1304-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.