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DRI Amphetamines Assay

Microgenics Corporation · Model 10014585 · UDI-DI 00884883004665

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

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.