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Pointe Methamphetamine Control (375 ng/mL) Level 1

HORIBA INSTRUMENTS INCORPORATED · Model 60-MP0714-5 · UDI-DI 00811727018366

LAS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Methamphetamine Control (375 ng/mL) Level 1 1 x 5 mL The Pointe Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on number of automated clinical chemistry analyzers.

Recalls

Date	Firm	Reason
2013-10-03	Lin-Zhi International Inc	Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

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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.