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Siemens Healthcare Diagnostics, Inc recalls SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quanti
Recalled August 13, 2014 · FDA recall Z-2150-2014 · Siemens Healthcare Diagnostics
Hazard
Complaints of failed calibration. · FDA Class II
Units
961 kits
Sold at
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Description
Complaints of failed calibration.
Product
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →