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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur XPT Immunoassay System
Recalled October 19, 2016 · FDA recall Z-0072-2017 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
292 units Total (3 domestically & 289 internationally)
Sold at
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
Description
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.
Product
ADVIA Centaur XPT Immunoassay System
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →