NA DUD-157-012-19Recalls & reported problems
Alere San Diego, Inc. · CLIA WAIVED Integrated E-Z Split Key Cup II (OX/SG/pH)+(NIT/GLUT/CRE)+OPI2000+AMP1000+(mAMP1000/COC300/THC50)) · 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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 ↗
Other Enzyme Immunoassay, Cannabinoids devices
- 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
- eScreen eReader V3Escreen, Inc. · Enzyme Immunoassay, Cannabinoids1 report
- NA DOA-264Alere San Diego, Inc. · Enzyme Immunoassay, Cannabinoids1 report
- ONLINE DAT Cannabinoids II 08771669190Roche Diagnostics GmbH · 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
- 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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