Z-1304-2024 Class II Ongoing
FDA device recall Z-1304-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on Feb 7, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 74,211 Kits (Expanded 2/28/24: additional 72,892 kits).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74,211 Kits (Expanded 2/28/24: additional 72,892 kits)
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%.
Distribution Pattern
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;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1304-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026