FDA Device Intelligence
HomeBIO-RAD LABORATORIES, INC. › TOX/See

TOX/See

BIO-RAD LABORATORIES, INC. · Model 194-5190 · UDI-DI 00847817000652

LAF
10
510(k) clearances
0
Adverse events
1
Recalls
64
Facilities

Description

TOX/See Drug Screen Test 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

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.