FDA Device Intelligence
Home › Microgenics Corporation › CEDIA Amphetamines/Ecstasy

CEDIA Amphetamines/Ecstasy

Microgenics Corporation · Model 100040 · UDI-DI 00884883004085

LAF
1
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

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.