NA DOA-1127-041-19Recalls & reported problems
Alere San Diego, Inc. · Integrated E-Z Split Key® Cup II (MET1000/MDMA500/THC50)+(BZO300/MTD300/BAR300)+(AMP1000/MOP300)+(OXY100/PPX300)+COC150+BUP10 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815845020789), received between May 23, 2018 and May 23, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (1 report).
1 FDA recall record name this device's 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, 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.
Recalls naming this device
- 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 · Recall details · FDA record ↗
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.
MalfunctionMay 23, 2018False Positive Result; False Positive Result
THE CUSTOMER REPORTED 12 INSTANCES OF FALSE POSITIVE COC, OPI, AND THC RESULTS AND 2 INSTANCES OF CONFLICTING OPI RESULTS BETWEEN AUGUST 2016 AND APRIL 2018. THE CUSTOMER WAS UNABLE TO PROVIDE THE FREQUENCY OF THE FALSE POSITIVE RESULTS FOR EACH SPECIFIED ANALYTE. CONFIRMATORY TESTING WAS PERFORMED AT (B)(6) TOXICOLOGY AND (B)(6) DETENTION CENTER FOR ALL 12 INSTANCES OF FALSE POSITIVE RESULTS. CONFIRMATORY TESTING PROVIDED NEGATIVE RESULTS EACH TIME FOR COC, OPI, AND THC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7539235 ↗
Other Radioimmunoassay, Tricyclic Antidepressant Drugs devices
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- iCup® I-DUA-157-013Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-167-022Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- reditest® 011020119Redwood Toxicology Laboratory, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs3 reports
- AlereTM iScreen® IS9Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- iCup® I-DOA-197-251Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- iCup® I-DUE-1107-141Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
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 · each recall links to the FDA recall notice
- 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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