reditest® 011020009Recalls & reported problems
Redwood Toxicology Laboratory, Inc. · PANEL 3 COC/M-AMP/THC · Class 2
Data updated Oct 13, 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 10858904006201), received between Sep 17, 2018 and Sep 17, 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. How this data works · Data updated Oct 13, 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.
MalfunctionSep 17, 2018False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE COC, MAMP, AND THC RESULTS ON BOTH STAFF AND PATIENTS. THE FALSE POSITIVE RESULTS OCCURRED ON 75 DEVICES OUT OF 75 DEVICES USED. NO CONFIRMATORY TESTING WAS PERFORMED AND NO ADVERSE PATIENT OUTCOMES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7883314 ↗
Other Radioimmunoassay, Tricyclic Antidepressant Drugs devices
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- iCup® I-DUA-167-022Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- Syva® Emit® tox™ Tricyclic Antidepressants Calibrator/Controls 10445390Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, TRICYCLIC ANTIDEPRESSANT DRUGS1 recall0 reports
- AlereTM iScreen® IS5MInstant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-157-013Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- reditest® 011020119Redwood Toxicology Laboratory, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs3 reports
- reditest® 011020012Redwood Toxicology Laboratory, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- reditest® 011020015Redwood Toxicology Laboratory, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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