Z-0214-2015Class III

ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with...

Name: Z-0214-2015 ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-09-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-09-12 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748... on 2014-09-12. FDA classified it as Class III and gives the reason as "Stability of the ADVIA Centaur Cleaning Solution is not assured". 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-0214-2015
Classification: Class III
Status: Terminated
Initiated: 2014-09-12
Posted: 2014-11-14
Terminated: 2015-07-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Stability of the ADVIA Centaur Cleaning Solution is not assured
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Siemens issued an Urgent Medical Device Recall (UMDR) to customers in the US on September 12, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 12, 2014. These notices inform the customer of the degradation of hypochlorite in these lots of cleaning solution. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm that the customers received the UMDR. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall For questions regarding this recall call 508-668-5000.
Quantity in commerce: 4645 (12 pk)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.
Product codes and lots: Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0214-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0214-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-14

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)