Gentamicin Flex Reagent Cartridge

• • Terminated Z-2182-2018 FDA Class II ·initiated 19 Apr 2018

  The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 g/mL [5.4 mol/L].

• • Terminated Z-2181-2018 FDA Class II ·initiated 19 Apr 2018

  The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.

510(k) Number

K962819 ↗

FDA Product Code

LCD

Device Class

Class II

Regulation

21 CFR Part 862.3450

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Dade Intl., Inc. →