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DCA Vantage® Analyzer
Siemens Healthcare Diagnostics Inc. · Model 10282969 · UDI-DI 00630414551364
1
510(k) clearances
37
Adverse events
7
Recalls
73
Facilities
Description
The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-06 | Siemens Healthcare Diagnostics, Inc. | processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) resu |
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2026-01-20 | Siemens Healthcare Diagnostics, Inc. | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 |
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
| 2024-08-22 | Healgen Scientific Llc | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results f |
| 2024-08-15 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions |
| 2024-08-15 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.