Recall Z-0072-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0072-2017
Creator: U.S. Food and Drug Administration
Published: 2016-04-28

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-04-28, terminated 2018-06-07. It names one FDA 510(k) clearance: K141999. Product: ADVIA Centaur XPT Immunoassay System. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Terminated: 2018-06-07
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K141999 — ADVIA CENTAUR TSHSiemens Healthcare Diagnostics, Inc.·cleared 2015-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ADVIA Centaur XPT Immunoassay System

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.