DCA Vantage® Analyzer 10282969Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00630414551364), received between Jun 18, 2020 and Sep 28, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K071466); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  The customer reported that they received a falsely elevated HBA1C result compared to retesting on the another DCA Vantage instrument. The controls were passing. There is no report of injury due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910828 ↗
• MalfunctionSep 24, 2026Low Test Results

  The customer reported that they received a falsely depressed HBA1C result compared to retesting on a lab instrument. The customer's correct HBA1C results were confirmed by the retest. The controls were passing. There is no report of injury due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877486 ↗
• MalfunctionSep 24, 2026High Test Results

  The customer reported that they received a falsely elevated HBA1C result compared to retesting on a lab instrument. Patient's HBA1C results were confirmed by retest. There is no report of injury due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877381 ↗
• MalfunctionSep 21, 2026High Test Results

  The customer reported that they received falsely elevated HBA1C results in 3 patient samples compared to retesting on the same DCA Vantage instrument. The controls were passing. There is no report of injury due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838982 ↗
• MalfunctionSep 21, 2026Low Test Results

  The customer reported that they received a falsely depressed HBA1C result compared to retesting on a an Atellica DCA instrument and also on another DCA Vantage ((b)(6)). The customer's correct HBA1C results were reported by retest. The controls were passing. There is no report of injury due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835623 ↗
• MalfunctionSep 14, 2026Low Test Results

  The customer reported that they received a falsely depressed HBA1C result compared to the continuous glucose monitoring (CGM) of the patient. The controls were passing. The patient's HBA1C result was confirmed from the repeat testing. There is no report of injury due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749437 ↗
• MalfunctionSep 1, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537439 ↗
• MalfunctionAug 14, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50247872 ↗
• MalfunctionAug 11, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206915 ↗
• MalfunctionJun 16, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSELY DEPRESSED HBA1C RESULT COMPARED TO RETESTING ON AN UNKNOWN LAB INSTRUMENT. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515998 ↗
• MalfunctionJun 5, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSELY DEPRESSED HBA1C RESULT COMPARED TO RETESTING ON AN UNKNOWN LAB INSTRUMENT. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406362 ↗
• MalfunctionMay 5, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSELY ELEVATED HBA1C RESULTS COMPARED TO RETESTING PERFORMED ON THE SAME DEVICE. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076580 ↗
• MalfunctionAug 7, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE OPERATOR TESTED A SAMPLE UNDER INCORRECT PATIENT ID. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735371 ↗
• MalfunctionJul 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT MICROALBUMIN, CREATININE AND ALBUMIN-CREATININE RATIO RESULT ON THEIR DCA VANTAGE INSTRUMENT COMPARED TO LAB TEST. THE PATIENT'S RESULTS WERE CONFIRMED FROM THE LAB TEST. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368544 ↗
• MalfunctionMar 28, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT THE DCA VANTAGE ANALYZER MIXED RESULTS FROM TWO DIFFERENT PATIENT SAMPLES TESTED WITH THE UNIQUE SAMPLE IDENTIFICATION (ID). THE DCA GENERATED RESULTS FROM A SAMPLE PROCESSED ON PATIENT-1, AND COMBINED THE RESULTS FROM A PATIENT-2 SAMPLE USING THE ID OF PATIENT-2. WHILE NO RESULTS WERE DISPLAYED FOR THE PATIENT-1 ID. RESULTS WERE REPORTED TO PHYSICIAN. NO DELAYED OR UNNECESSARY TREATMENT/MEDICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21716453 ↗
• MalfunctionApr 25, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER ALLEGED THAT THE OPERATOR'S EYES WERE EXPOSED TO HBA1C REAGENT MIXED WITH PATIENT BLOOD. EXPOSURE OCCURRED WHILE THE OPERATOR WAS RUNNING A HBA1C SAMPLE. THE OPERATOR PULLED THE BUFFER TAB ON THE HBA1C REAGENT AND THE REAGENT MIXED WITH BLOOD SAMPLE SPRAYED THEIR EYES. THE OPERATOR WAS NOT WEARING EYE PROTECTION WHEN THE INDENT OCCURRED. FOLLOWING THE EXPOSURE THE OPERATOR USED THE EYE WASH STATION BUT DID NOT SEEK MEDICAL ATTENTION. CUSTOMER STATED THE OPERATOR IS DOING WELL.

  Patient problems: Exposure to Body Fluids

  MAUDE report 19184687 ↗
• MalfunctionJul 25, 2023Low Test Results; Low Test Results

  CUSTOMER STATED THAT DISCREPANT LOW MICROALBUMIN AND CREATININE RESULTS WERE OBTAINED WHEN COMPARED TO ANOTHER DCA SYSTEM. THE ISSUE OCCURRED WITH TWO DIFFERENT SAMPLES. THERE IS NO REPORT OF HARM DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391243 ↗
• MalfunctionApr 27, 2022Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT THEY HAD ONE INCIDENT WHERE THE RESULTS OF ONE PATIENT WERE REPORTED TO A DIFFERENT PATIENT'S ID. THERE HAS BEEN NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219086 ↗
• MalfunctionSep 22, 2021Smoking; Smoking

  THE CUSTOMER REPORTED THAT THEY SAW SMOKE COMING FROM THEIR DCA VANTAGE ANALYZER. THE ANALYZER WAS IMMEDIATELY UNPLUGGED. THERE WAS A STRONG BURNING SMELL PRESENT AT THE POWER CORD. NO FLAMES WERE SEEN, BUT SMOKE WAS VISIBLE. NO SAMPLE WAS BEING RUN AT THAT TIME. THERE WAS NO REPORT OF INJURY TO ANY PATIENT OR OPERATOR DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515233 ↗
• MalfunctionJun 18, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  INTERNAL TESTING HAS DETERMINED THAT THE DCA VANTAGE EXTERNAL BARCODE SCANNER MODEL DS4308 DOES NOT OPERATE AS INTENDED WHEN USING CODE 39 WITH CHECK DIGIT ENABLED BARCODES. THERE IS A REMOTE POSSIBILITY OF INCORRECT IDENTIFICATION OF PATIENT RESULTS BY THE MEDICAL DEVICE WHEN USING THIS BARCODE SCANNER TO SCAN PATIENT IDS WITH THE INDICATED SYMBOLOGY. THERE HAVE BEEN NO REPORTS OF INJURY DUE TO THIS DEFECT FROM CUSTOMERS.

  Patient problems: No Patient Involvement

  MAUDE report 10169455 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071466. One submission often covers many models, so check the product and lot details in each record.

• Z-2747-2020 · Jun 30, 2020 · Terminated
  DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US