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First Sign®
HEMOSURE INC. · Model FSCDIPMD-25 · UDI-DI 00817763022084
LAF
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
65
Facilities
Description
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived MDMA
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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Get your free API keyRead the docsData 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.