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Alere San Diego, Inc. · Model DOA-1105-021 · UDI-DI 10815845021045
10
510(k) clearances
8
Adverse events
2
Recalls
48
Facilities
Description
One Step Multi-Drug, Multi-Line Screen Test Device (AMP1000/COC300/THC50)+(mAMP1000/OPI2000/PCP25)+(BZO300/BAR300)+MTD300+MDMA500
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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