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McKesson

MCKESSON MEDICAL-SURGICAL INC. · Model 16-5125A3 · UDI-DI 20612479228751

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10
510(k) clearances
8
Adverse events
2
Recalls
48
Facilities

Description

Drugs of Abuse Test 12-Drug Panel with Adulterants:

Recalls

DateFirmReason
2026-06-26Siemens 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
2003-11-17Abbott 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.