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ECO® V Cup

W.H.P.M. INC. · Model ECOV-3464 · UDI-DI 00841824104372

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510(k) clearances

Adverse events

Recalls

Facilities

Description

DOA 6 in 1 Test ECO V Cup, 25Pcs/Box, CLIA Waived, AMP/COC/mAMP/MOR/PCP/THC

Recalls

Date	Firm	Reason
2021-02-05	OraSure 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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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.