Skip to content

iCup® I-DUE-1107-141Recalls & reported problems

Instant Technologies, Inc. · Class 2

All models of iCup (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10858945006284), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • False Positive Result1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 23, 2019False Positive Result; False Positive Result

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE PATIENT WAS TESTED ON THE 10 PNL INTEGRATED CUP DEVICE AND RECEIVED A FALSE POSITIVE COCAINE (COC) RESULT. CONFIRMATION LAB TESTING WAS PERFORMED. NO FURTHER INFORMATION WOULD BE PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8819020 ↗

Other Radioimmunoassay, Tricyclic Antidepressant Drugs devices

All Radioimmunoassay, Tricyclic Antidepressant Drugs devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page