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Recall Observatory FDA recall evidence

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

February 11, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.device_software_design · v1.0.0

    issue with ADVIA Chemistry XPT software