ADVIA Chemistry XPT Chemistry Systems — Class II medical device recall Z-0183-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-11-04. ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective ele
| Recall number | Z-0183-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2015-08-28 |
| Classified | 2015-10-29 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2018-05-22 |
| Countries outside the US | AU, BH, DE, DK, EG, ES, FI, FR, GB, IT, KR, NL, NO, NZ, SG, SK |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0183-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.