Z-0164-2015Class II

Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

Name: Z-0164-2015 Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2014-09-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-09-26 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) on 2014-09-26. FDA classified it as Class II and gives the reason as "Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0164-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Posted: 2014-12-16
Terminated: 2016-01-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 26, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 26, 2014. These notices inform the customer of the positive bias with ADVIA Centaur Systems Cortisol and Progesterone when calibrated with Calibrator E kit lots ending in 38 and 39.Customers may continue use of the affected lots as the clinical utility of the assay is not impacted. The communications also provide information on the performance of the assays when they use Calibrator E kit lots ending in 40. The notices should be reviewed with the facility's laboratory or Medical director. All affected domestic customers were sent a hard copy of the Urgent Medical Device Correction via Federal Express. Fax-back forms will be used to confirm that the customers received the UMDC. 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 Correction and completed the required actions. All affected customers outside the US will be provided a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer will be required to return a completed confirmation fax-back to Siemens. 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 Field Safety Notice and completed the required actions.
Quantity in commerce: Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)
Distribution: Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Unit.Arab Emir., Vatican, Yemen, AR, AU, BD, BR, CA , CH, CL, CN, CO, DO, EC, EG, GT, HK, ID, IE, IL, IN, JP, KR, LY, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VN, ZA
Product codes and lots: 26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0164-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0164-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-10-31

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)