Dario LC Blood Glucose Monitoring System 1138-05Recalls & reported problems
Labstyle Innovation Ltd · The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dario LC blood glucose meter is a small all-in-one meter that plugs into a smartphone for power and shows results on the phone. The 46 reports mostly describe readings that seemed wrong — often higher than another meter, or repeated tests a minute apart giving different results. No deaths and no injuries are reported. No recalls name this device. Reports have dropped from 27 in the previous 12 months to 9 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00850065006154), received between Jun 30, 2024 and May 20, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (46 reports).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings46
- High Readings30
- Low Readings7
- High Test Results1
Patient problems
- Hyperglycemia30
- Insufficient Information10
- Hypoglycemia8
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 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 FROM HIS DARIO METER FOUR CONSECUTIVE BG READINGS ONE MINUTE APART WITH A 100 MG/DL DIFFERENCE BETWEEN SOME OF THE READINGS. THE USER ALSO STATED THAT HE WAS USING A NEW CARTRIDGE OF STRIPS WITH AN EXPIRATION DATE OF FEBRUARY 2027.
Patient problems: Hyperglycemia
MAUDE report 25234688 ↗MalfunctionApr 19, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON MARCH 23TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 97 MG/DL FROM HER DARIO METER COMPARED TO A BG READING OF 131 MG/DL FROM HER LABWORK.
Patient problems: Hypoglycemia
MAUDE report 24921204 ↗MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON MARCH 5TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT FIVE DAYS PRIOR, HIS BG READINGS ON HIS DARIO METER CHANGED BY 30 MG/DL TO 40 MG/DL WITHOUT THE USER HAVING CHANGED HIS DIET OR EXERCISE. THE USER ALSO REPORTED THAT HE PERFOMED CONSECUTIVE BG TESTS SIXTY SECONDS APART USING THE SAME FINGER PRICK AND HE RECEIVED BG READINGS THAT WERE 10 MG/DL TO 15 MG/DL LESS. FURTHERMORE, THE USER ALSO STATED THAT HE PERFORMED THESE BG TESTS THREE TIMES IN THE PAST TWO DAYS AND RECEIVED A BG READING OF 159 MG/DL ON THE FIRST TEST AND 129 MG/DL ON THE THIRD TEST.
Patient problems: Insufficient Information
MAUDE report 24744434 ↗MalfunctionMar 18, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON FEBRUARY 19TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER, WHO IS A NURSE, REPORTED RECEIVING BG READINGS FROM HER DARIO METER THAT WERE 14 MG/DL TO 15 MG/DL HIGHER THAN HER NON-DARIO METER. THE USER REPORTED THAT AFTER FEELING SYMPTOMATIC FOR HYPOGLYCEMIA, SHE TESTED HER BG USING THE DARIO METER AND RECEIVED READINGS IN NORMAL RANGE, WHILE RECEIVING BG READINGS IN THE HYPOGLYCEMIC RANGE FROM HER NON-DARIO METER. THE USER REQUESTED THAT CONTROL SOLUTION BE SENT TO HER.
Patient problems: Hypoglycemia
MAUDE report 24630286 ↗MalfunctionFeb 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON JANUARY 22ND, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED TESTING HIS DARIO STRIPS USING CONTROL SOLUTION AND RECEIVING RESULTS THAT WERE OUT OF RANGE FOR THE LEVEL 2 CONTROL SOLUTION TEST. IN ADDITION, THE USER REPORTED RECEIVING BG READINGS FROM HIS DARIO METER THAT WERE LESS THAN THE BG READINGS THAT HE RECEIVED FROM HIS NON-DARIO METER.
Patient problems: Hypoglycemia
MAUDE report 24410552 ↗MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING FROM HIS DARIO METER A BG READING OF 61 MG/DL COMPARED TO A BG READING OF 100 MG/DL FROM HIS NON-DARIO METER.
Patient problems: Hypoglycemia
MAUDE report 24327171 ↗MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER INCONSISTENT BG READINGS TOWARDS THE END OF THIRTY DAYS OF USAGE. THE USER ALSO REPORTED THAT SHE COMPARES THE BG READINGS THAT SHE RECEIVES FROM HER DARIO METER WITH A NON-DARIO METER, TESTING AT THE SAME TIME, AND USING THE SAME DROP OF BLOOD. THE USER STATED THAT AFTER OPENING A NEW CARTRIDGE OF STRIPS, THE USER RECEIVES A 10 MG/DL DIFFERENCE IN BG READINGS BETWEEN HER DARIO METER AND HER NON-DARIO METER, HOWEVER SEVERAL WEEKS LATER, THE USER RECEIVES BG READINGS WITH A 50 MG/DL TO 100 MG/DL DIFFERENCE BETWEEN HER TWO METERS. THE USER FURTHER REPORTED THAT HER A1C RESULTS ARE MORE ALIGNED WITH THE BG READINGS THAT SHE RECEIVED FROM HER NON-DARIO METER, WHICH ARE LOWER THAN THE BG READINGS THAT SHE RECEIVES FROM HER DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 24324348 ↗MalfunctionJan 22, 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 FROM HIS DARIO METER A BG READING OF 213 MG/DL COMPARED TO A BG READING OF 163 MG/DL FROM HIS NON-DARIO METER AND CGM.
Patient problems: Hyperglycemia
MAUDE report 24148398 ↗MalfunctionDec 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON NOVEMBER 29TH, THE USER CONTACTED DARIO TO REPORT INSONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER CONSECUTIVE BG READINGS OF 122 MG/DL, 85 MG/DL, AND 108 MG/DL USING THE SAME FINGER AND DROP OF BLOOD. THE USER STATED THAT THESE READINGS DID NOT ALIGN WITH HOW SHE FELT. THE USER REPORTED THAT SEVERAL DAYS LATER SHE TESTED USING HER DARIO METER WITH THE SAME FINGER AND DROP OF BLOOD AND RECEIVED A BG READING OF 131 MG/DL, FOLLOWED BY A READING OF 114 MG/DL.
Patient problems: Insufficient Information
MAUDE report 23903660 ↗MalfunctionOct 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON SEPTEMBER 18TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING HIGH BG READINGS FROM HER DARIO METER WHEN COMPARED TO THE BG READINGS THAT SHE RECEIVED FROM HER OTHER METER, WHICH SHE RECEIVED FROM HER DOCTOR.
Patient problems: Hyperglycemia
MAUDE report 23317654 ↗MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON AUGUST 27TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER HIGH BG READINGS AFTER OPENING HIS STRIPS CARTRIDGE SEVEN DAYS PRIOR. THE USER STATED THAT HE OPENED AND TESTED WITH A NEW CARTRIDGE OF STRIPS, AND HIS BG READINGS WERE IN NORMAL RANGE FOR HIM.
Patient problems: Hyperglycemia
MAUDE report 23096181 ↗MalfunctionSep 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON AUGUST 26TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER BG READINGS RANGING FROM 100 MG/DL TO 220 MG/DL WITHIN A 24 HOUR PERIOD. IN ADDITION, THE USER REPORTED THAT SHE CONTINUES TO RECEIVED BG READINGS THAT ARE OVER 200 MG/DL. THE USER STATED THAT UNTIL THIS ISSUE OCCURED, THE USER HAD NEVER RECEIVED A BG READING ABOVE 120 MG/DL. DUE TO THE ABOVE, THE USER PURCHASED A NON-DARIO METER, WHICH SHE TESTED WITH AND RECEIVED A BG READING OF 99 MG/DL.
Patient problems: Hyperglycemia
MAUDE report 23072389 ↗MalfunctionSep 12, 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 RECEIVING FROM HER DARIO METER FIVE COMPLETELY DIFFERENT READINGS WHEN TESTING HER BG FIVE TIMES IN A ROW.
Patient problems: Insufficient Information
MAUDE report 23037529 ↗MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON AUGUST 10TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING FROM HER DARIO METER BG READINGS THAT WERE 50 MG/DL HIGHER THAN HER NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 22991813 ↗MalfunctionAug 13, 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 FROM HER DARIO METER A BG READING OF 168 MG/DL COMPARED TO A BG READING OF 134 MG/DL FROM HER NON-DARIO METER. THE USER ALSO STATED THAT HER SHIPMENT OF DARIO METER, TEST STRIPS AND SUPPLIES WAS LEFT ON HER DOORSTEP IN VERY HOT WEATHER CONDITIONS.
Patient problems: Hyperglycemia
MAUDE report 22794624 ↗MalfunctionAug 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON JULY 6TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER BG READINGS OF 119 MG/DL AND 130 MG/DL ONE MINUTE LATER, COMPARED TO BG READINGS OF 108 MG/DL AND 111 MG/DL FOUR MINUTES LATER FROM HER NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 22725770 ↗MalfunctionJul 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 HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS IN THE RANGE OF 212 MG/DL TO 279 MG/DL FROM HER DARIO METER COMPARED TO A BG READING OF 142 MG/DL FROM HER OTHER DEVICE.
Patient problems: Hyperglycemia
MAUDE report 22579727 ↗MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON MAY 23RD THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS THAT ACCORDING TO HER, ARE INACCURATE, INCLUDING BG READINGS THAT ARE GREATLY VARYING WHEN TESTING CONSECUTIVELY. THE USER STATED THAT DESPITE TAKING TROUBLESHOOTING STEPS, THE INCONSISTENT BG READINGS PERSIST.
Patient problems: Insufficient Information
MAUDE report 22309856 ↗MalfunctionJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON MAY 21ST, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED THAT HIS DARIO METER WAS NOT FUNCTIONING PROPERLY.
Patient problems: Insufficient Information
MAUDE report 22293752 ↗MalfunctionJun 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6) 2025, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS ON HIS DARIO METER THAT ARE 20 MG/DL HIGHER THAN THE BG READINGS THAT HE RECEIVED ON HIS NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 22285063 ↗MalfunctionJun 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT (B)(6) WAS THE FIRST DAY SHE STARTED USING THE DARIO METER. THE USER STATED THAT SHE WAS NOT COMPARING THE BG READINGS THAT SHE RECEIVED WITH THE DARIO METER TO ANY OTHER METER.
Patient problems: Hypoglycemia; Insufficient Information
MAUDE report 22208632 ↗MalfunctionJun 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON MAY 13TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING LOWER BG READINGS AND EA1C FROM HIS DARIO METER WHEN COMPARED TO THE RESULTS THAT HE RECEIVED FROM HIS VETERAN AFFAIRS (VA) MEDICAL FACILITY. THE USER STATED THAT FOR THE PAST SEVERAL MONTHS, HE RECEIVED FROM HIS DARIO METER AN EA1C OF LESS THAN 7%, AND IS CURRENTLY 5.7%. THIS RESULT IS COMPARED TO THE A1C OF 7.9% THAT THE USER RECEIVED FROM HIS VA MEDICAL FACILITY ON MAY 9TH. IN ADDITION, THE USER STATED THAT THE EA1C THAT HE RECEIVED FROM HIS DARIO METER HAS BEEN SIGNIFICANTLY LOWER THAN 7% FOR AT LEAST NINETY DAYS. THE USER ALSO REPORTED THAT ON MAY 9TH, HE RECEIVED BG READINGS OF 100 MG/DL AND 104 MG/DL FROM HIS DARIO METER COMPARED TO A BG READING OF 146 MG/DL THAT HE RECEIVED FOM HIS VA MEDICAL FACILITY, BOTH READINGS BEING TAKEN THIRTY MINUTES APART.
Patient problems: Hypoglycemia
MAUDE report 22196126 ↗MalfunctionJun 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON MAY 6TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS OF 96 MG/DL, 199 MG/DL, AND 292 MG/DL FROM HER DARIO METER, ALL WITHIN A FEW MINUTES.
Patient problems: Hyperglycemia; Insufficient Information
MAUDE report 22152687 ↗MalfunctionJun 3, 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 STATED THAT HER DARIO METER IS NOT READING HER BG LEVEL CORRECTLY.
Patient problems: Hyperglycemia
MAUDE report 22134153 ↗MalfunctionMay 8, 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 HIGHER BG READINGS WHILE TESTING WITH THE SAME FINGER USING HIS DARIO METER WHEN COMPARED TO HIS NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 21982966 ↗
Other System, Test, Blood Glucose, Over The Counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page