RELION 09409963001Recalls & reported problems
Wal-Mart Stores, Inc. · RELION PLATINUM 100CT STRIPS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00681131403283), received between Sep 11, 2023 and Nov 25, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 Readings4
- High Test Results3
- Low Test Results2
- Imprecise or Erratic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Hypoglycemia1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 192 MG/DL AND 89 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23648821 ↗MalfunctionSep 9, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 156 MG/DL WITH THE RELION SYSTEM AND 87 MG/DL WITH A PROFESSIONAL METER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001722 ↗MalfunctionApr 30, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 199 MG/DL AND 99 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932890 ↗MalfunctionJan 17, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 88 MG/DL, 113 MG/DL, 123 MG/DL AND 223 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21177761 ↗MalfunctionJan 16, 2025Low Test Results; Low Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 20 MG/DL AND 65 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21166184 ↗MalfunctionJul 11, 2024High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 192 MG/DL,104 MG/DL AND 99 MG/DL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725124 ↗MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 107 MG/DL (USER'S METER) AND LO (< 20 MG/DL; USER'S SECOND ROCHE METER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18652492 ↗MalfunctionNov 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: HI (= HIGHER THAN THE MEASUREMENT RANGE OF THE METER, 600 MG/DL) AND A RESULT IN THE "100'S" ( MG/DL).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18232642 ↗MalfunctionNov 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 197 MG/DL, 88 MG/DL AND 161 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18140531 ↗MalfunctionSep 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 74 MG/DL AND 376 MG/DL. THE CUSTOMER WAS SWEATING AND BELIEVES HER BLOOD GLUCOSE WAS LOW AND THAT THE 74 MG/DL READING WAS CORRECT. THE CUSTOMER RETRIEVED AND DRANK SODA AND MILK, AND ATE SANDWICH TO SELF-TREAT. SHE FELT FINE AFTERWARDS. NO TREATMENT OR OUTSIDE ASSISTANCE WAS REQUIRED.
Patient problems: Hypoglycemia
MAUDE report 17724579 ↗
Other System, Test, Blood Glucose, Over The Counter devices
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- 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.
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