Z-0515-2018Class II

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810...

Name: Z-0515-2018 ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2017-06-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-06-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756 on 2017-06-07. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots...". 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-0515-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2018-02-04
Terminated: 2019-05-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Product code: CHP Radioimmunoassay, Estradiol
Reason for recall: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States who have received ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct customers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots ending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform customers who operate ADVIA Centaur CP systems to continue using their inventory of C3021, as they are not impacted by this issue. All affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via Federal Express. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall letter.
Quantity in commerce: 5992 units (US and OUS)
Distribution: US and OUS.
Product codes and lots: Lot Numbers: 00387A21, 16673A21, 36243A21; 00388A21, 15448A21, 51211A21; 20640A21; 51024A21. Expiration Date: 2018-03-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0515-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0515-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-04

Product code CHP

K100293Class IIAdvia Centaur Calibrator 30, Models 10379811/10379810Siemens Heatlhcare Diagnostics, Inc. / cleared 2010-03-19

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)