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Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2

HORIBA INSTRUMENTS INCORPORATED · Model 60-PP0256-5 · UDI-DI 00811727017987

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a 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.