iCupRecalls & reported problems across all models
Instant Technologies, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one iCup model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of iCup by Instant Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2018 and Jul 23, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
iCup recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1589-2022 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗
Most reported iCup problems
Device problems
- False Positive Result3
Patient problems
- No Consequences Or Impact To Patient3
iCup models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iCup® I-DUA-157-013Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-167-022Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DOA-197-251Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- iCup® I-DUE-187-071Enzyme Immunoassay, Cocaine And Cocaine Metabolites1 report
- iCup® I-DUE-1107-141Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
Recent iCup adverse event reports
The 3 most recent reports across all models, 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 ↗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 ↗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 ↗
Other Instant Technologies, Inc. products
All Instant Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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