MEDLINE MPHD122A3CRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20193489017547), received between May 13, 2026 and Sep 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K182701); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026False Negative Result

  It was reported that the device was showing false negative result.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927508 ↗
• MalfunctionSep 24, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891879 ↗
• MalfunctionSep 23, 2026False Negative Result

  It was reported that the device is producing false negatives.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872131 ↗
• MalfunctionSep 23, 2026Unable to Obtain Readings

  It was reported that "Multiple cups did not temp" and "the cup read no temp".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869569 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The report states, "We ordered 16 boxes of these at the end of July. We use these mainly for the BUP. There were at least 5 in one day that came back negative for this drug. We had to send these out to our lab for confirmation, which did come back positive for the drug. This occurred several days. Drug cups are no longer used due to false negative results."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866807 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The report states, "We ordered 16 boxes of these at the end of July. We use these mainly for the BUP. There were at least 5 in one day that came back negative for this drug. We had to send these out to our lab for confirmation, which did come back positive for the drug. This occurred several days. Drug cups are no longer used due to false negative results."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866806 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The report states, "We ordered 16 boxes of these at the end of July. We use these mainly for the BUP. There were at least 5 in one day that came back negative for this drug. We had to send these out to our lab for confirmation, which did come back positive for the drug. This occurred several days. Drug cups are no longer used due to false negative results."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866805 ↗
• MalfunctionSep 18, 2026False Positive Result

  It was reported that "Customer is receiving a lot of false positive results".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822646 ↗
• MalfunctionSep 15, 2026False Negative Result

  It was reported that "Drug testing cup MPHD122A3C, LOT W512505016 cups will produce a negative result for Suboxone showing a faint line, and we verified with a different drug test that the test should be positive and there should be no line visisble."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773577 ↗
• MalfunctionSep 2, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573456 ↗
• MalfunctionMay 13, 2026False Negative Result

  IT WAS REPORTED THAT FALSE NEGATIVES ARE BEING PROVIDED WHILE USING THE DRUG SPECIMEN CUPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164243 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182701. One submission often covers many models, so check the product and lot details in each record.

• Z-1589-2022 · May 25, 2022 · Open, Classified
  Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z