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Triage

QUIDEL CARDIOVASCULAR INC. · Model 94400EU · UDI-DI 30014613337904

LAFLDPDKZDJGLCMLDJDISJXOMLKJXMDJR Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
65
Facilities

Description

Triage TOX Drug Screen (OUS)

Recalls

DateFirmReason
2021-02-05OraSure Technologies, Inc.Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.