Z-0860-2015Class II

ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro...

Name: Z-0860-2015 ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-10-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-10-09 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests on 2014-10-09. FDA classified it as Class II and gives the reason as "A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress". 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-0860-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Posted: 2014-12-23
Terminated: 2017-03-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Quantity in commerce: 10,515 units total
Distribution: Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Product codes and lots: Product Codes: 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696 and 10471899.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0860-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0859-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0860-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code JJE

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