MEDLINE MPH50025MRecalls & reported problems
Medline Industries, Inc. · TEST,MONO,CASS,25 TEST · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 30888277191895), received between May 7, 2026 and Sep 29, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 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 Readings16
- False Negative Result13
- False Positive Result2
- Improper or Incorrect Procedure or Method2
- No Device Output2
- Clumping in Device or Device Ingredient1
- Device Ingredient or Reagent Problem1
- Display Difficult to Read1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "We have two patients that have tested positive on the Medline kit and negative on the Osom kit. We reran the patients on both kits again and still have medline showing as positive and Osom showing as negative."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931059 ↗MalfunctionSep 28, 2026Missing Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926118 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "One of my 2 Mono boxes failed the QC."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914839 ↗MalfunctionSep 25, 2026Clumping in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings
It was reported that 1BX OF TESTS ARE DISPLAYING 3 LINES INSTEAD OF 2. CONTROL LINE, TEST LINE, AND UNKNOWN MIDDLE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896213 ↗MalfunctionSep 24, 2026False Negative Result
It was reported that "when we ran the controls, the tests did not react to the positive control giving us a false negative result. We tried a couple of different tests and also tried the controls from the previous box and still had the same false negative results."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883858 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that the positive control is not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871083 ↗MalfunctionSep 23, 2026Device Ingredient or Reagent Problem
It was reported that "The positive control in the kit is not working."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870271 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method
It was reported that "Testing the test kit and both the positive and the negative showed up as negative."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867549 ↗MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "One box of Medline brand mono test kits failed QC tests 2 times."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867169 ↗MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840892 ↗MalfunctionSep 19, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831980 ↗MalfunctionSep 18, 2026False Negative Result
It was reported that "THE POSITIVE CONTROL IS NOT COMING UP POSITIVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822052 ↗MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "On our positive patient line on patients and when running QC the line is not going fully across the window. It only goes halfway."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809776 ↗MalfunctionSep 17, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808854 ↗MalfunctionSep 15, 2026False Negative Result
It was reported that "2 kits are testing negative."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773459 ↗MalfunctionSep 12, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746774 ↗MalfunctionSep 10, 2026No Device Output; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721498 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "the Postive does not flag the negative context when in use."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719199 ↗MalfunctionSep 10, 2026Unable to Obtain Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718421 ↗MalfunctionSep 9, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702308 ↗MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674596 ↗MalfunctionSep 4, 2026False Negative Result
It was reported that "There have been issues with the positive control not showing positive." It was also reported that "the positive test line is often very faint and we had a couple of true positives that came up negative on the new kit."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616202 ↗MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614236 ↗MalfunctionSep 4, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50612105 ↗MalfunctionSep 3, 2026Display Difficult to Read
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594207 ↗
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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