Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0072-2017 — ADVIA Centaur XPT Immunoassay System

U.S. FDA — Device Enforcement · United States · 2016-04-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0072-2017
Date of alert
2016-04-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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