MEDLINE MPH70025CTRecalls & reported problems
Medline Industries, Inc. · TEST,IFOBT,CASSETTES/TUBES · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30888277360017), received between Sep 22, 2026 and Sep 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Visual Prompts/Feedback” (1 report).
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
- No Visual Prompts/Feedback1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026No Visual Prompts/Feedback
It was reported that "Customer is experiencing issues with the tests showing No Control Line. Tests from both boxes are having the same reaction, no control line".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856917 ↗
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- McKesson 127-50ERMckesson Medical-Surgical Inc. · Reagent, Occult Blood1 recall0 reports
- McKesson 4487Mckesson Medical-Surgical Inc. · Reagent, Occult Blood1 recall0 reports
- Urisys 1100 Urine Analyzer 3617556001Roche Diagnostics GmbH · REAGENT, OCCULT BLOOD7 reports
- MEDLINE MPH70025CTMMedline Industries, Inc. · REAGENT, OCCULT BLOOD1 report
- HemaPrompt FG HPFGAerscher, Inc · Reagent, Occult Blood1 report
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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