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Pointe Methamphetamine Reagent Set

HORIBA INSTRUMENTS INCORPORATED · Model 60-MP0700-100 · UDI-DI 00811727018304

LAF Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Methamphetamine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methamphetamine Reagent Set is intended for the qualitative and semi-quantitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

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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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.