DCA Systems HbA1c Reagent Kit
Published March 27, 2024 · Recall initiated: February 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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%.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the country of Taiwan.
- Lot
- Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot#: 9640093, 0645103, 0648103, 0649103, 0654103 . Expanded Lots (02/28/2024): 0637093, 0641093, 0642093, 0647103, 0653103, 0655103;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.