FDA-Device2017-04-19Class II
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
ORTHO-CLINICAL DIAGNOSTICS
Hazard
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.
Sold states
Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
Affected count
US: 6324; Foreign: 1868
Manufactured in
FELINDRE MEADOWS, N/A, Bridgend, N/A, United Kingdom
Products
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1765-2017Don't want to check this manually?
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