FDA-Device2014-05-14Class II
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Siemens Healthcare Diagnostics
Hazard
Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.
Sold states
Nationwide and internationally
Affected count
5,900 units total (1,679 domestically & 4,221 internationally)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1553-2014Don't want to check this manually?
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