Z-0183-2016Class II

ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical...

Name: Z-0183-2016 ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-08-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-08-28 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma... on 2015-08-28. FDA classified it as Class II and gives the reason as "ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC...". 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-0183-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-28
Posted: 2015-10-30
Terminated: 2018-05-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Correction letters (dated 8/27/2015) and Field Correction Effectiveness Check Forms were sent to customers via FedEx starting on 8/28/2015, informing them of the potential for discrepant ISE results. Customers must follow the instructions provided in the letter. The Actions to Be Taken section of the letter notes that customers must ensure that the electrodes are fully plugged in after replacement, washing or maintenance activities, followed by performing an ISE Calibration and running 2 levels of Quality Control material. Urgent Field Safety Notices were sent to customers outside the USA. The Field Correction Effectiveness Check form should have been completed and returned. A copy of the letter should be kept with laboratory records; and, the letter should be forwarded to anyone who may have received the affected product. Customers should contact their Siemens Customer Care Center or their local Siemens technical support representative with questions.
Quantity in commerce: Domestic: 15 units; Foreign: 59 units
Distribution: Worldwide Distribution -- US, Australia, Bahrain, Denmark, Egypt, Egypt, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Republic Korea, Singapore, Slovakia, Spain, and the United Kingdom.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-29

Product code JGS

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)