Medline MPH6550Recalls & reported problems
Medline Industries, Inc. · STRIP,TEST,GLUCOSE,HARMONY · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277675681), received between Sep 23, 2026 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings3
- Display or Visual Feedback Problem1
- Unable to Obtain Readings1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown
It was reported that "Issues with blood glucose strips not reading correctly".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949548 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "The products are not reading a specific range required for the test."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941718 ↗MalfunctionSep 28, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917605 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "They are all out of the control range."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871490 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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