FDA-Device2016-01-13Class II

Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

Siemens Healthcare Diagnostics Inc
Hazard

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Sold states
Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Affected count
1157
Manufactured in
2 Edgewater Dr, N/A, Norwood, MA, United States
Products
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0610-2016

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