Z-0800-2014Class II

Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run...

Name: Z-0800-2014 Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-12-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-12-17 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine on 2013-12-17. FDA classified it as Class II and gives the reason as "An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits...". 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-0800-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-17
Posted: 2014-01-21
Terminated: 2014-08-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
Root cause tag: software
FDA root cause: Software design
Action: The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.
Quantity in commerce: 1563
Distribution: Worldwide Distribution. USA nationwide and the country of Canada.
Product codes and lots: ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0800-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-21

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)