Recall Z-1399-2015 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
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 h
| Date | Apr 7, 2015 (initiated Feb 11, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Siemens Healthcare Diagnostics sent Urgent Medical Device Correction Letters (dated 2/11/2015) via FedEx to the domestic consignees informing users of the software issue with ADVIA Chemistry XPT Software Version 1.0.2. The letters included work instructions to handle the bug. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. For questions about in process samples, the event message 02 981 8728, or need assistance with mitigation solutions, please contact your Siemens Customer Care Cente |
| Quantity | 16 units: 3 Domestic, 13 Foreign |
| Distribution | Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |