Z-0346-2014Class II

ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific...

Name: Z-0346-2014 ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific...
Creator: Siemens Healthcare Diagnostics
Published: 2013-09-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-09-03 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and... on 2013-09-03. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0346-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-03
Posted: 2013-11-18
Terminated: 2017-03-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
Root cause tag: software
FDA root cause: Software design
Action: On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).
Quantity in commerce: 876 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Product codes and lots: Product Code: 10639265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0346-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0343-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18
Z-0344-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18
Z-0345-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18
Z-0346-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code JGS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)