Z-1078-2016Class II

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075...

Name: Z-1078-2016 Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2016-02-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-02-04 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur Calibrator E For in vitro diagnostic... on 2016-02-04. FDA classified it as Class II and gives the reason as "ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay". 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-1078-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-04
Posted: 2016-03-08
Terminated: 2017-08-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare issued an Urgent Medical Device Correction (UMDC) to all affected Siemens Healthcare Diagnostics customers in the United States on February 4, 2016 to be delivered to customers on February 5, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on February 4, 2016. These notices inform the customers of the lot to lot bias of Calibrator E with the ADVIA Centaur Testosterone assay and advise customers to move to Calibrator E kit lots ending in 44. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Correction. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative
Quantity in commerce: 6455 (6 pack)
Distribution: Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA
Product codes and lots: Lot code/ Exp.Date: 86344A42 May 9, 2016; 55437A42 May 9, 2016; 54801A42 May 9, 2016; 53651A42 May 9, 2016; 53625A42 May 9, 2016; 15610A43 November 27, 2016; 18375A43 November 27, 2016; 24990A43 November 27, 2016; 38988A43 November 27, 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1078-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1077-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1078-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08
Z-1079-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code JIX

K932955Class ICiba Corning Acs Progesterone ImmunoassayCiba Corning Diagnostics Corp. / cleared 1993-08-02

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)