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Biomerieux France Chemin De L'Or recalls VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments
Recalled September 21, 2016 · FDA recall Z-2779-2016 · Biomerieux France Chemin De L'Or
Hazard
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. · FDA Class III
Units
229 kits
Sold at
US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.
Description
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Product
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
Manufacturer(s)
Biomerieux France Chemin De L'Or
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →