FDA-Device2014-11-26Class III
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
Siemens Healthcare Diagnostics, Inc
Hazard
Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.
Sold states
Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.
Affected count
100 test - 4,600 kits; 500 test - 1,878 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2015Don't want to check this manually?
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