Z-1390-2012

Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50...

Name: Z-1390-2012 Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-03-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-03-06 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA... on 2012-03-06. The reason FDA records is "Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims". 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-1390-2012
Status: Terminated
Initiated: 2012-03-06
Posted: 2012-04-09
Terminated: 2015-06-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.
Product code: JFT Fluorometric, Cortisol
Reason for recall: Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Siemens Healthcare, sent an "Urgent Field Safety Notice" via e-mail to all affected customers on March 6, 2012 in the United States and International. The Urgent Field Safety Notice describe the product, problem, and actions to be taken. The notice instructed the customers to perform daily calibration on all Cortisol reagent kits to maintain consistently accurate quality control and patient values; to complete and return the confirmation fax-back form 'Field Correction Effectiveness Check' via fax to the Technical Solutions Center at (302) 631-7597 and forward this notification to whomever they many have distributed this product. If you have any questions, contact Quality Engineer 5- Quality Systems and Compliance at 508-660-8540 or www.siemens.com/diagnostics.
Quantity in commerce: Total: 40023. 50 Test Kits = 21734;250 Test Kits= 15879;250 REF Test Kits= 2410
Distribution: Worldwide distributed: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRALIA, BANGLADESH, BD, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, EGYPT, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, JAPAN, KOREA, MALAYSIA, MEXICO, NEW ZEALAND, PAKISTAN, PHILIPPINES, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, TAIWAN, THAILAND, URUGUAY, VENEZUELA, and VIETNAM.
Product codes and lots: AD VIA Centaur¿ Cortisol reagent kit lots from the reagent lots ending with the following three digits: 254, 255, 256, 257. Kit Lot# 50 Test 70078254 70860254 72058254 73346254 74543254 75397254 76332255 77366255 78595255 79146255 80596255 81274255 82938256 83522256 84771256 86150257 250 Test 69991254 70470254 73049254 74027254 76202255 78071255 80179255 81497255 82689256 83316256 86138257 250 Test 73880254 77890255 80812255 83456256 86151257 Not Applicable . Expiry Date 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 15 Feb 2013 09 May 2013 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 09 May 2013 05 May 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 09 May

Product code JFT

K962559Class IIAcs Cortisol ImmunoassayCiba Corning Diagnostics Corp. / cleared 1996-11-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)