eCUP + Drug Screening Device 94615Recalls & reported problems
Ameditech Inc. · 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816565021530), received between May 2, 2023 and Mar 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Smoking” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Smoking1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Smoking
THE CUSTOMER REPORTED SEEING VISIBLE SMOKE COMING FROM THE POWER JACK IN THE BACK OF AN EREADER+ INSTRUMENT. NO OTHER EVIDENCE OF FIRE (E.G., BURNING, SPARKING, CHARRING, SPARKING, MELTED PLASTIC, ELECTRICAL DISCHARGE) WAS OBSERVED. NO INJURY OR OTHER ADVERSE HEALTH OUTCOME WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562602 ↗MalfunctionMay 2, 2023Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THAT THE EREADER+ INSTRUMENT SHOCKED A CLINICIAN WHEN THEY WERE ADJUSTING THE INSTRUMENT'S CONNECTION TO THE ADJACENT COMPUTER. REPORTEDLY, THE SHOCK OCCURRED WHEN TOUCHING THE USB CORD THAT CONNECTED THE INSTRUMENT TO THE BACK OF THE COMPUTER. THE CLINICIAN DID NOT WANT TO TROUBLESHOOT THE ISSUE FURTHER, DUE TO FEAR OF GETTING SHOCKED AGAIN. NO INJURY AND/OR MEDICAL INTERVENTION WAS NOTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857807 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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