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Alere San Diego, Inc. · Model DOA-1124-011 · UDI-DI 10815845020901
10
510(k) clearances
8
Adverse events
2
Recalls
49
Facilities
Description
One Step Drug Screen Test Card (COC300/AMP1000/mAMP1000/THC50/MTD300/MDMA500/OPI2000/OXY100/PCP25/BAR300/BZO300)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens Healthcare Diagnostics, Inc. | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h |
| 2003-11-17 | Abbott Health Products, Inc. | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.