Siemens DCA HbA1c Reagent Kit Recalled for Inaccurate Test Results
Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device with a confirmed measurement defect. No illnesses or injuries have been reported, but the device poses a significant risk of harm through inaccurate test results that could lead to incorrect patient care decisions.
Plain-English summary
Siemens Healthcare Diagnostics is recalling specific lots of its DCA Systems HbA1c Reagent Kit, a diagnostic device used to measure blood glucose levels. The device has a confirmed defect where it displays a positive bias without alerting the user. Testing compared the affected lots to reference samples and found a maximum bias of 19%.
This defect could result in erroneous test results being reported to patients and healthcare providers. Incorrect results could potentially lead to incorrect patient management of glucose control.
The recall includes specific lot numbers: 9640093, 0645103, 0648103, 0649103, 0654103, 0637093, 0641093, 0642093, 0647103, 0653103, and 0655103. The affected kits were distributed in the United States nationwide and in Taiwan.
The recalled product
- Product
- DCA Systems HbA1c Reagent Kit
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distributed nationwide across the United States.
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