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RTCII 2nd gen.
AMERICAN BIO MEDICA CORPORATION · Model 10-8MOX3-030 · UDI-DI 10694644500339
1
510(k) clearances
8
Adverse events
2
Recalls
48
Facilities
Description
RTCII MINICUP THC/COC150/METH500/OPI300/BUP/OXY/MTD/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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