Z-0720-2018Class II

ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of...

Name: Z-0720-2018 ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2017-07-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-07-28 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur... on 2017-07-28. FDA classified it as Class II and gives the reason as "Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0720-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Posted: 2018-02-26
Terminated: 2019-04-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
Reason for recall: Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Siemens sent an Urgent Medical Device Correction letter dated July 28, 2017, that was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States. On August 15, 2017 Follow-up communication was sent to all customers. For further questions, please call (508) 668-5000.
Quantity in commerce: 33,298
Distribution: Worldwide Distribution - US Distribution.
Product codes and lots: x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0720-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-26

Product code CDP

K041133Class IIModification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC / cleared 2004-07-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)