Z-0072-2017Class II

ADVIA Centaur XPT Immunoassay System

Name: Z-0072-2017 ADVIA Centaur XPT Immunoassay System
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-04-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-04-28 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur XPT Immunoassay System on 2016-04-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0072-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Posted: 2016-10-12
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur XPT Immunoassay System
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens sent an Urgent Medical Device Correction letter dated April 28, 2016, to all affected customers. The letter advised customers not to release results generated by the system if quality control results are not within acceptable ranges. Customers were advised to perform the following steps to check the Setting for the Daily Maintenance Task frequency on your instrument: *Open the Maintenance Tab, * Select Daily Maintenance task and * Verify that the Frequency Column is set to "Daily at..". The Daily Maintenance Task frequency setting can only be reset by a Siemens Customer Service engineer. If your instrument is set to "As Needed": Daily Maintenance Task Frequency Setting May be Incorrect. Customers should contact their local Technical Support Center to schedule a visit by your Siemens Customer Service engineer. Customers should also perform the daily maintenance by selecting the Daily Maintenance Task and then selecting Perform on the right bar. In addition, all customers were asked to complete and return the Field Correction Effectiveness Check within 30 days. For questions regarding this recall call 914-631-8000.
Quantity in commerce: 292 units Total (3 domestically & 289 internationally)
Distribution: 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
Product codes and lots: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0072-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0072-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-12

Product code JLW

K141999Class IIAdvia Centaur TshSiemens Healthcare Diagnostics, Inc. / cleared 2015-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)