ADVIA Chemistry XPT System — Class II medical device recall Z-1399-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-04-15, distributed in AZ, CA, WA. Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The sys
| Recall number | Z-1399-2015 |
|---|---|
| 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 | 2015-02-11 |
| Classified | 2015-04-07 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-03-02 |
| Distributed | AZ, CA, WA |
| Countries outside the US | DE, ES, GB, IT |
| Reason classes | software |
| Lot numbers | CA1275000050005, CA1275000060006, CA1275000070007, CA1275000080008, CA1275000090009, CA1275000100010, CA1275000120012, CA1275000130013, CA1275000170017, CA1275000200020, CA1275000220022, CA1275000240024, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000410041 |
Product
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, 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.
Reason for recall
Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is held Inprocess will not transmit to the LIS. Manual intervention is necessary to complete the processing of the samples that are held Inprocess.
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-1399-2015. 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.