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McKesson

MCKESSON MEDICAL-SURGICAL INC. · Model MCK03-4490 · UDI-DI 10612479258430

LFG DRJ DJG DIS LCM DJC LDJ DIO JXM DKZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Test Kit, Drug Screen Cup, 14-Panel, Waived

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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Data 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.