reditest® 011020015Recalls & reported problems
Redwood Toxicology Laboratory, Inc. · PANEL 5 COC/M-AMP/THC/OPI/BZO · Class 2
Data updated Oct 16, 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 10858904006249), received between Aug 25, 2017 and Aug 25, 2017 — 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 16, 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.
MalfunctionAug 25, 2017False Positive Result; False Positive Result
THE CUSTOMER REPORTED 40 OCCURRENCES OF FALSE POSITIVE RESULTS ON ALL DRUGS USING THE MULTI-DRUG 5 PANEL SCREEN ON RANDOM DONORS STARTING IN (B)(6) OF 2017. TESTING AT AN EXTERNAL LABORATORY PROVIDED NEGATIVE RESULTS. THE CUSTOMER REPORTED THAT OUT OF 325 DEVICES USED, 40 PRODUCED FALSE POSITIVE RESULTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6822697 ↗
Other Radioimmunoassay, Tricyclic Antidepressant Drugs devices
- NA DOA-1127-041-19Alere San Diego, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall1 report
- AlereTM iScreen® IS5MInstant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-167-022Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 recall0 reports
- iCup® I-DUA-157-013Instant 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
- reditest® 011020119Redwood Toxicology Laboratory, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs3 reports
- AlereTM iScreen® IS9Instant Technologies, Inc. · Radioimmunoassay, Tricyclic Antidepressant Drugs1 report
- reditest® 011020183Redwood 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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