Medline MPH1560Recalls & reported problems
Medline Industries, Inc. · CONTROL,EVENCARE G2 HI LO · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884389102544), received between Sep 23, 2026 and Sep 30, 2026 — classified as 8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
- Low Readings4
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950157 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949739 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "her EvenCare G2 meter was reading out of range when she tested the control solutions." It was reported that "both the high and low read out of range."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948416 ↗MalfunctionSep 29, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937483 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932107 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "THEY OPENED A NEW BOX OF SOLUTIONS AND IS NOT READING WITHIN RANGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922955 ↗MalfunctionSep 25, 2026Low Readings
It was reported that "LOT # 16822092102/202 IS READING LOW. TEST RAN AND CAME BACK AT 50 AND THE BOTTLE OF STRIPS PERAMETERES ARE 53-79."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898056 ↗MalfunctionSep 23, 2026Low Readings
It was reported that these controls are not giving accurate readings. The low solutions are giving readings that are way too low and inaccurate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872055 ↗
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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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