RecallRadar

FDA Device recall Z-0072-2017

ADVIA Centaur XPT Immunoassay System

On 2016-10-19 the FDA classified a Class II recall of ADVIA Centaur XPT Immunoassay System by Siemens Healthcare Diagnostics, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0072-2017
ClassificationClass II
Statusterminated
Initiated2016-04-28
Published2016-10-19
Last updated2026-09-13 11:54 UTC
CompanySiemens Healthcare Diagnostics
DistributionCA, DE, IN, MD, MN, MS

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.

Identifiers

code_infoNone

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0072-2017%22

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