Medline MPHD141A3CRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20193489017554), received between Aug 25, 2026 and Sep 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Negative Result; False Positive Result

  It was reported that "THEIR ROSEBURG SITE IS NOTICING ON THE UDS CUPS THAT ARE INSTANT THEY ARE NOT COMING UP POSITIVE AND WHEN THEY SEND FOR CONFIRMATION THE PATIENT IS POSITIVE. HAS HAD TWO INSTANCES SO FAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945532 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The report states that the controls failed for COC, MTD, and Oxy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930950 ↗
• MalfunctionSep 22, 2026False Negative Result

  It was reported that "recently had an incident in which a patient who is known to use THC testing negative. We had an employee with a prescription for benzos use a cup as well, also testing negative."

  Patient problems: Insufficient Information

  MAUDE report 50854492 ↗
• MalfunctionAug 25, 2026False Positive Result

  It was reported that the device was showing a false positive for cocaine.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50423394 ↗
• MalfunctionAug 25, 2026False Positive Result

  It was reported that the device was showing a false positive for cocaine.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50423238 ↗
• MalfunctionAug 25, 2026False Positive Result

  It was reported that the device was showing a false positive for cocaine.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422968 ↗
• MalfunctionAug 25, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422501 ↗
• MalfunctionAug 25, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422375 ↗

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