Z-0940-2014Class II

Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400

Name: Z-0940-2014 Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-11-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-11-06 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as... on 2013-11-06. FDA classified it as Class II and gives the reason as "The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC)". 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-0940-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Posted: 2014-02-09
Terminated: 2015-08-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Medical Device Correct letter, dated November 6, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain the recall notification letter with their laboratory records and forward to those who may have received the affected product.
Quantity in commerce: 3759
Distribution: Worldwide Distribution and USA Nationwide.
Product codes and lots: ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0940-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-08

Product code JJE

K990346Class IIBayer Advia 1650 Chemistry SystemBayer Corp. / cleared 1999-05-21

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)