Z-0510-2013Class II

Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in...

Name: Z-0510-2013 Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-11-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-11-14 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination... on 2012-11-14. FDA classified it as Class II and gives the reason as "Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used". 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-0510-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Posted: 2012-12-11
Terminated: 2015-09-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
Product code: LFM Enzyme Immunoassay, Digitoxin
Reason for recall: Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers. These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature range to 20 -25 degrees C and for the DHEAS assay to reduce the instrument operating temperature range to 18 -26 degrees C when these assays are being used. These notices also direct customers to review the contents of the correction notice with their Laboratory Director or Medical Director. A confirmation fax-back form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local technical support representative. For questions regarding this recall call 508-668-5000.
Quantity in commerce: 50 test=792 and 250 test=525
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0510-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0506-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11
Z-0507-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11
Z-0508-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11
Z-0509-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11
Z-0510-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11
Z-0511-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11
Z-0512-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11

Product code LFM

K970546Class IIAcs DigitoxinChiron Diagnostics Corp. / cleared 1997-07-14

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)