FDAFDA · Food and drugs·Recall number Z-2150-2014
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.
Published August 13, 2014 · Recall initiated: June 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints of failed calibration.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- 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.
- Lot
- Lot# 38059172 and 39463172
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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