FDA Device recall Z-1399-2015
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT…
- FDA Device
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT… by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1399-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-11 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AZ, CA, WA |
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
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.
Identifiers
| code_info | Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA127500007000…Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA1275000070007, CA1275000130013, CA1275000100010, CA1275000120012, CA1275000170017, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000240024, CA1275000200020, CA1275000220022, CA1275000410041 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1399-2015%22
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