Medline MPHD121A3CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20193489017530), received between Sep 9, 2026 and Sep 21, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842387 ↗
• MalfunctionSep 9, 2026False Positive Result

  Patient problems: Insufficient Information

  MAUDE report 50693722 ↗

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