NA DOA-264Recalls & reported problems
Alere San Diego, Inc. · One Step Drug Screen Test Card (COC/AMP/mAMP/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 10815845020888), received between Aug 12, 2017 and Aug 12, 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 12, 2017False Positive Result; False Positive Result
THE CUSTOMER REPORTED RECEIVING POSITIVE COC AND AMP RESULTS ON EVERY 6 PANEL SCREEN TEST FROM MOST RECENT BATCH. THE CUSTOMER REPORTED RECEIVING THREE POSITIVE COC AND AMP RESULTS ON ONE PATIENT URINE SAMPLE USING THE 6 PANEL SCREEN TEST. THE CUSTOMER ALSO REPORTED RECEIVING INVALID RESULTS FOR BZO. THE RESULTS WERE CONFIRMED NEGATIVE USING ANOTHER 6 PANEL DRUG TEST. NO TREATMENT OR INTERVENTION WAS PROVIDED BASED ON THE RESULTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6790812 ↗
Other Enzyme Immunoassay, Cannabinoids devices
- NA DUD-157-012-19Alere San Diego, Inc. · Enzyme Immunoassay, Cannabinoids1 recall0 reports
- NA DOA-2167-19Alere San Diego, Inc. · Enzyme Immunoassay, Cannabinoids1 recall0 reports
- T-Cup TDOA-1145A3Wondfo USA CO., Ltd. · Enzyme Immunoassay, Cannabinoids1 recall0 reports
- T-Cup TDOA-1145A3Wondfo USA CO., Ltd. · Enzyme Immunoassay, Cannabinoids1 recall0 reports
- Alere iCup Dx Pro 2 I-DXP-2107-01Instant Technologies, Inc. · Enzyme Immunoassay, Cannabinoids1 recall0 reports
- ONLINE DAT Cannabinoids II 08771669190Roche Diagnostics GmbH · Enzyme immunoassay, cannabinoids1 report
- eScreen eReader V3Escreen, Inc. · Enzyme Immunoassay, Cannabinoids1 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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