Alere Triage® 94400EURecalls & reported problems
Alere San Diego, Inc. · Alere Triage® TOX Drug Screen · Class 2
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 00899722002757), received between May 8, 2017 and May 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative 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 Negative 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 8, 2017False Negative Result; False Negative Result
THE CUSTOMER REPORTED THE FOLLOWING EVENT OCCURRING ON ONE PATIENT: ON (B)(6) 2017, THE PATIENT'S URINE SAMPLE WAS TESTED WITH THE TRIAGE TOX DRUG SCREEN PANEL AND PRODUCED A NEGATIVE COCAINE RESULT. THE TRIAGE TOX DRUG SCREEN PANEL COCAINE THRESHOLD CONCENTRATION IS 300 NG/ML. AN IMMUNOCHROMATOGRAPHY INLAB COCAINE TEST WAS PERFORMED AND PRODUCED A POSITIVE RESULT. THE CUT-OFF POINT FOR THE INLAB COCAINE TEST IS 300 NG/ML. THE SAMPLE WAS SENT TO (B)(6) LABORATORY (KIMS METHODOLOGY) AND ON (B)(6) 2017 A POSITIVE RESULT COCAINE WAS RECEIVED. THE COCAINE DECISION LEVEL FOR THE (B)(6) LABORATORY TEST IS 150 NG/ML. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6553177 ↗
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
- 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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