MEDLINE MPHD101A3CRecalls & reported problems
Medline Industries, Inc. · TEST, DRUG, 10 PANEL, A.D, 25/BX · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20193489017516), received between Sep 11, 2026 and Sep 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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.
Reports received per month
Most reported problems
Device problems
- False Negative Result3
- Incorrect, Inadequate or Imprecise Result or Readings2
- Display Difficult to Read1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026False Negative Result
It was reported that the iotem is giving false negatives on the BUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947003 ↗MalfunctionSep 29, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933035 ↗MalfunctionSep 21, 2026Display Difficult to Read; False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842600 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733590 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733589 ↗
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, ClassifiedDrugs 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
Other TEST, AMPHETAMINE, OVER THE COUNTER devices
- MEDLINE MPHD122A3CMedline Industries, Inc. · TEST, AMPHETAMINE, OVER THE COUNTER11 reports
- Medline MPHD141A3CMedline Industries, Inc. · TEST, AMPHETAMINE, OVER THE COUNTER8 reports
- Medline MPHD121A3CMedline Industries, Inc. · TEST, AMPHETAMINE, OVER THE COUNTER2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.