Dario® USB-C Blood Glucose Monitoring System - Starter Kit 1265-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00850065006758), received between Apr 29, 2024 and May 20, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K150817, K172723); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON APRIL 20TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER A BG READING OF 156 MG/DL.

  Patient problems: Hyperglycemia

  MAUDE report 25230282 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ON MARCH 3RD, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT HE COMPARED HIS DARIO METER TO HIS CGM AND THERE IS A THIRTY PERCENT DIFFERENCE BETWEEN THE TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 24741902 ↗
• MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON JANUARY 14TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER HIGH READINGS WHEN TESTING WITH CONTROL SOLUTION.

  Patient problems: Insufficient Information

  MAUDE report 24326893 ↗
• MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON JANUARY 9TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT THE BG READINGS THAT SHE RECEIVED FROM HER DARIO METER WHEN COMPARED TO HER NON-DARIO METER ARE NOT ALIGNED.

  Patient problems: Hyperglycemia

  MAUDE report 24290474 ↗
• MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 239 MG/DL FROM HIS DARIO METER COMPARED TO A BG READING OF 115 MG/DL FROM HIS NON-DARIO METER.

  Patient problems: Hyperglycemia

  MAUDE report 24087302 ↗
• MalfunctionSep 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6), THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT HE USES HIS CGM (CONTINUOUS GLUCOSE MONITOR) TO MEASURE HIS BG AND ACCORDING TO THE MEASUREMENT, INJECTS INSULIN. THE USER REPORTED RECEIVING BG READINGS OF 160 MG/DL AND 111 MG/DL FROM HIS DARIO METER COMPARED TO A BG READING OF 121 MG/DL FROM HIS CGM.

  Patient problems: Insufficient Information

  MAUDE report 23031868 ↗
• MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 147 MG/DL FROM HER DARIO METER COMPARED TO A BG READING OF 121 MG/DL FROM HER OLD METER WHILE PERFORMING A SIDE-BY-SIDE BG TEST WITH THE SAME DROP OF BLOOD. THE USER STATED THAT HER OLD METER WAS CALIBRATED RECENTLY AT HER DOCTOR'S OFFICE.

  Patient problems: Hyperglycemia

  MAUDE report 23002283 ↗
• MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON (B)(6) THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT SHE PURCHASED A DARIO METER FOR HER NIECE, WHO RECEIVED BG READINGS OF OVER 400 MG/DL. DUE TO THE ABOVE, THE USER'S NIECE WENT TO THE DOCTOR, WHERE HER BG WAS TESTED WITH THE DOCTOR'S METER AND READ 109 MG/DL. THE USER ALSO REPORTED THAT SINCE HER NIECE RECEIVED A DEVICE FROM HER DOCTOR, SHE TESTS SIDE-BY-SIDE WITH THIS METER AND HER DARIO METER, USING THE SAME DROP OF BLOOD, AND THAT THE DARIO METER IS STILL GIVING A HIGH BG FOR THE USER'S NIECE.

  Patient problems: Hyperglycemia

  MAUDE report 22829400 ↗
• MalfunctionAug 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JULY 10TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER FASTING BG READINGS OF 154 MG/DL, 158 MG/DL, 183 MG/DL AND 210 MG/DL WITHIN THREE MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 22767948 ↗
• MalfunctionApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON MARCH 29TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED THAT HER DARIO METER WAS GIVING HER BG READINGS THAT WERE SLIGHTLY HIGH, HOWEVER DID NOT SPECIFY THE RESULTS.

  Patient problems: Hyperglycemia

  MAUDE report 21926792 ↗
• MalfunctionFeb 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON (B)(6), THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A LOW EA1C OF 5.6% FROM HIS DARIO METER WHEN COMPARED TO AN A1C OF 7.0% FROM THE BG READINGS THAT THE USER RECEIVED FROM HIS DOCTOR'S TESTING.

  Patient problems: Hyperglycemia

  MAUDE report 21442505 ↗
• MalfunctionJan 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON DECEMBER 4TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING THE FOLLOWING INCONSISTENT FASTING BG READINGS FROM HIS DARIO METER WHEN COMPARED TO HIS NON-DARIO METER: DARIO NON-DARIO 160 121 111 150 100 123 149 114 134 122 93 128 153 134 183 155 133 111 321 143 96 117.

  Patient problems: Insufficient Information

  MAUDE report 21053217 ↗
• MalfunctionJun 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT SEVERAL DAYS PRIOR TO CONTACTING DARIO, HE TESTED HIS BG LEVEL AND SUSPECTED THAT HIS RESULTS WERE INACCURATE. THE USER STATED THAT HE TESTED HIS BG LEVEL AND THEN IMMEDIATELY TESTED AGAIN AND RECEIVED A 10 MG/DL DIFFERENCE BETWEEN THESE TWO BG TESTS. ON THE MORNING OF (B)(6) PRIOR TO SPEAKING WITH DARIO'S REPRESENTATIVE, THE USER TESTED HIS BG LEVEL AND RECEIVED BG READINGS OF 92 MG/DL, 134 MG/DL AND 165 MG/DL.

  Patient problems: Insufficient Information

  MAUDE report 19570456 ↗
• MalfunctionApr 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  ON MARCH 29TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A DIFFERENCE OF ABOUT 100 MG/DL WHEN TESTING HIS BG LEVEL BETWEEN HIS NEW DARIO METER AND HIS TWO NON-DARIO METERS. THE USER REPORTED RECEIVING A BG READING OF 115 MG/DL FROM HIS DARIO METER WHEN COMPARED TO A BG READING OF 215 MG/DL FROM ONE OF HIS NON-DARIO METERS.

  Patient problems: Hypoglycemia

  MAUDE report 19209124 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150817, K172723. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2020 · Aug 29, 2019 · Terminated
  Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2