FDA-Device2014-10-08Class II
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Siemens Healthcare Diagnostics
Hazard
The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full
Sold states
Worldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.
Affected count
Domestic: 2771 units; Foreign: 7744 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2716-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief