Device 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.
Z-1399-2015
Product summary
- Event
- Event 70591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units: 3 Domestic, 13 Foreign
- Official record key
device-enforcement:Z-1399-2015
Official wording
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.
Code information: Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA1275000070007, CA1275000130013, CA1275000100010, CA1275000120012, CA1275000170017, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000240024, CA1275000200020, CA1275000220022, CA1275000410041
Distribution pattern: Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK.
Derived failure modes
-
Device software or design
issue with ADVIA Chemistry XPT software