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Pointe Hydrocodone 100 Level 1 Control (75 ng/mL)

HORIBA INSTRUMENTS INCORPORATED · Model 60-HY0774-5 · UDI-DI 00811727016751

LAS Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
24
Facilities

Description

Pointe Hydrocodone 100 Level 1 Control (75 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers.

Recalls

DateFirmReason
2013-10-03Lin-Zhi International IncProduct 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.