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Easy@Home Multi-Drug Screen Test (5 tests kit)

EASY HEALTHCARE CORPORATION · Model EDOAP-144 · UDI-DI 00850253007871

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

Description

5 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET

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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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.