Z-0755-2016Class II

ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests...

Name: Z-0755-2016 ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-10-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-10-07 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid... on 2015-10-07. FDA classified it as Class II and gives the reason as "Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS)...". 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-0755-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-07
Posted: 2016-02-04
Terminated: 2018-05-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.
Root cause tag: software
FDA root cause: Software design
Action: On October 7, 2015 Siemens Healthcare Diagnostics distributed Urgent Field Safety Notices to their custoemrs via Fed Ex in the U.S. and via email to regional countries for implementation outside of the U.S. Customers were provided a work-around if they have experienced any of the following problems: 1) Intermittent auto-startup function fails, 2) calibration interval resets as though a full calibration was performed, 3) Users may be unaware that the QC definition screen with +/- suggests a 2 Standard Deviation range value, 4) a rescanned and re-queried sample may become stuck in a communication loop and all tests may read as "inprocess" if the the initial reaction process is incomplete, 5) The printer stops printing if multiple printouts are requested in quick succession, 6) the ISE calibration for Urine Sodium (Na) may fail due to the ranges being set conservatively during development, 7) The automatic or manually started, archiving and deletion maintenance activity may fail and 8) A workstation services restart screen may appear under multiple scenarios causing the interface to be temporarily inaccessible. If customers have experienced any of the previously mentioned workflow problems, please perform the following actions: 1. Auto Start Failing: Manually perform the Startup Wash, run controls and any calibrations that are due. 2. Calibration interval resets when an RBL is run: Calibration should be run according to the recommendations in the Instructions for Use (IFU) for each assay. Keep a record of required calibrations and ensure that all assays are calibrated before use. 3. Control definition screen assumes that the range is defined as 2 SD values: When creating QC definitions, enter the values associated with a +/- 2 Standard Deviation (SD) range in the +/- ranges field.4. Laboratory Information System (LIS) communication / Laboratory Automation (LAS) issue: Be aware of errors in the event log and take action as needed. Manual intervention and rerunning
Quantity in commerce: 87 units
Distribution: Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.
Product codes and lots: Software Version 1.0.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0755-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0755-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-04

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)