FDA-Device2016-10-19Class II
ADVIA Centaur XPT Immunoassay System
Siemens Healthcare Diagnostics, Inc.
Hazard
The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.
Sold states
Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN
Affected count
292 units Total (3 domestically & 289 internationally)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur XPT Immunoassay System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2017Don't want to check this manually?
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