iCup® I-DOA-197-251Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10858945006062), received between Jul 3, 2018 and Jul 3, 2018 — 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

Recent adverse event reports

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

• MalfunctionJul 3, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE COCAINE RESULT USING THE ALERE TOXICOLOGY ICUP 9 DRUG PANEL FOR ONE DONOR URINE SPECIMEN AS COMPARED TO A NEGATIVE LABORATORY CONFIRMATORY RESULT (LC/MS/MS CUT-OFF=100 NG/ML). THE CUSTOMER REPORTED THAT ONLY ONE FALSE POSITIVE COCAINE RESULT OCCURRED OUT OF 100 DEVICES USED. NO TREATMENT WAS PROVIDED OR WITHHELD BASED ON THE FALSE POSITIVE RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659218 ↗