Skip to content

iCup® I-DUE-187-071Recalls & 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 10858945006178), received between Feb 8, 2019 and Feb 8, 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.

  • MalfunctionFeb 8, 2019False Positive Result; False Positive Result

    UNSPECIFIED DATE: FALSE POSITIVE COC AND MAMP ON MULTIPLE DONORS WHEN TESTING WITH THE 8 PANEL ICUP AS COMPARED TO RESULTS IN THE LAB. NO TREATMENT WAS PROVIDED OR WITHHELD BASED ON THE FALSE POSITIVE RESULTS. NO ADVERSE OUTCOMES REPORTED. ALTHOUGH FURTHER INFORMATION WAS REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8324331 ↗

Other Enzyme Immunoassay, Cocaine And Cocaine Metabolites devices

All Enzyme Immunoassay, Cocaine And Cocaine Metabolites devices →

Sources and updates

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