Vitros Immunodiagnostic Products Nt Pro-Bnp Reagent Pack, Calibrators, Range Verifiers, 680 2156, 680 2157, 680 2158

• • Ongoing Z-0689-2019 FDA Class II ·initiated 1 Nov 2018

  The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

• • Terminated Z-1765-2017 FDA Class II ·initiated 7 Mar 2017

  Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.

510(k) Number

K060632 ↗

FDA Product Code

NBC

Device Class

Class II

Regulation

21 CFR Part 862.1117

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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