The ADVIA Chemistry XPT Chemistry System — Class II medical device recall Z-2014-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2021-07-14, distributed nationwide. ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligne
| Recall number | Z-2014-2021 |
|---|---|
| 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 | 2021-05-18 |
| Classified | 2021-07-06 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2024-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, BR, CA, CL, CN, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IN, IT, KR, MY, NL, NO, NZ, PT, SA, SE, SK, TH, TR, TW, VN |
| Quantity | 842 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00630414595467 |
Product
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.
Reason for recall
ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result
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-2014-2021. 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.