Dario LC Starter Kit 1147-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00850065006253), received between Jun 27, 2024 and May 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ON APRIL 13TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER A BG READING OF 159 MG/DL FROM ONE TEST STRIP CARTRIDGE COMPARED TO A BG READING OF 128 MG/DL FROM A DIFFERENT TEST STRIP CARTRIDGE. THE USER REPORTED THAT BOTH CARTRIDGES HAD THE SAME LOT NUMBER AND EXPIRATION DATE, BEING THE 15TH OF APRIL. THE USER ALSO REPORTED THAT HE TESTED HIS BG SEVERAL TIMES USING BOTH TEST STRIP CARTRIDGES, AND EACH TIME HE RECEIVED A 30 MG/DL DIFFERENCE IN BG READINGS BETWEEN THE TWO CARTRIDGES.

  Patient problems: Insufficient Information

  MAUDE report 25158286 ↗
• MalfunctionMay 5, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON APRIL 7TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING HIGH BG READINGS FROM HIS DARIO METER WHEN COMPARED TO THE READINGS THAT HE RECEIVED FROM TWO OTHER NON-DAIRO METERS. THE USER ALSO STATED THAT THE BG READINGS FROM THE NON-DARIO METERS WERE TAKEN BY REGISTERED NURSES.

  Patient problems: Hyperglycemia

  MAUDE report 25076947 ↗
• MalfunctionDec 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  ON NOVEMBER 4TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING AN A1C OF 12.8% FROM HER LABWORK, COMPARED TO AN ESTIMATED A1C OF 7.6% ALONG WITH AN AVERAGE BG READING OF 168 MG/DL FROM HER DARIO METER. THE USER ALSO STATED THAT SHE HAD COMPARED THE READINGS FROM HER DARIO METER AGAINST MULTIPLE OTHER NON-DARIO METERS AND FOUND THAT HER DARIO METER WAS CONSISTENTLY READING LOWER.

  Patient problems: Hypoglycemia

  MAUDE report 23719599 ↗
• MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6), DARIO'S REPRESENTATIVE CONTACTED THE USER IN ORDER TO FOLLOW UP REGARDING THE REPLACEMENT METER THAT THE USER RECENTLY RECEIVED. THE USER REPORTED A DIFFERENCE IN THE RANGE OF 15 MG/DL TO 20 MG/DL IN HER BG READINGS WHEN PERFORMING CONSECUTIVE TESTS WITH HER DARIO METER.

  Patient problems: Insufficient Information

  MAUDE report 23301955 ↗
• MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Low Readings

  ON (B)(6), THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER, WHO HAS TWO DARIO METERS, REPORTED RECEIVING A BG READING OF 35 MG/DL FOLLOWED BY A BG READING OF 520 MG/DL FROM ONE OF THE DARIO METERS. THE USER STATED THAT SHE STORES ONE DARIO METER IN HER PURSE, AND THE OTHER AT HOME.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 23002816 ↗
• MalfunctionAug 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON JULY 13TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER A BG READING OF 418 MG/DL COMPARED TO A BG READING OF 129 MG/DL FROM HIS NON-DARIO METER, WHICH HE RECEIVED APPROXIMATELY 40 MINUTES LATER. THE USER STATED THAT HIS NORMAL BG RANGE IS 129 MG/DL.

  Patient problems: Hyperglycemia

  MAUDE report 22784362 ↗
• MalfunctionMay 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON APRIL 28TH, THE USER CONTACTED DARIO TO REPORT HIGH AND INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER BG READINGS THAT WERE 25 MG/DL HIGHER AND VARYING WHEN HE PERFORMED CONSECUTIVE TESTS.

  Patient problems: Hyperglycemia

  MAUDE report 22078457 ↗
• MalfunctionSep 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  ON AUGUST 7TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT A COUPLE OF MONTHS AGO, HE BEGAN RECEIVING LOW BG READINGS FROM HIS DARIO METER COMPARED TO THE BG READINGS FROM HIS DEXCOM METER AND HIS OTHER NON-DARIO METER. DUE TO THE ABOVE, THE USER REPORTED THAT HE BROUGHT HIS DARIO METER WITH HIM TO THE DOCTOR IN ORDER TO COMPARE HIS BG READINGS WITH THE DOCTOR'S METER.

  Patient problems: Hypoglycemia

  MAUDE report 20155897 ↗
• MalfunctionJul 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Low Readings

  ON (B)(6) 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 77 MG/DL FOLLOWED BY A BG READING OF 121 MG/DL FROM HIS DARIO METER.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 19749386 ↗
• MalfunctionJul 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Low Readings

  ON JUNE 10TH, 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 158 MG/DL FROM HIS DARIO METER. DUE TO THIS BG READING, THE USER OPENED A NEW CARTRIDGE OF STRIPS, WHERE HE TESTED AND RECEIVED A BG READING OF 89 MG/DL, WHICH THE USER STATED IS WITHIN HIS NORMAL FASTING RANGE OF 80 MG/DL TO 100 MG/DL. THE USER ALSO REPORTED THAT HE RECEIVED BG READINGS OF 79 MG/DL ON APRIL 28TH, 64 MG/DL ON MAY 12TH, AND 52 MG/DL ON MAY 26TH, WITHOUT EXPERIENCING ANY HYPOGLYCEMIC SYMPTOMS. DUE TO THESE LOW BG READINGS, THE USER DISCARDED THREE STRIP CARTRIDGES.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 19702414 ↗
• MalfunctionJun 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON (B)(6) 2024, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT HE STARTED RECEIVING HIGH BG READINGS ALL OF A SUDDEN.

  Patient problems: Hyperglycemia

  MAUDE report 19627659 ↗

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