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Terminated

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.

FDA Recall Z-1399-2015 · Posted 2015-04-07

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJGS
Date Initiated2015-02-11
Date Terminated2017-03-02
Product Quantity16 units: 3 Domestic, 13 Foreign

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.

Firm 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 Center or your local Siemens Technical Support Representative. Urgent Field Safety Notice Letters were sent to the foreign consignees (distribution is determined at the country level). Field service personnel were notified of the Urgent Medical Device Correction Letter.

Root Cause

Software design

Distribution Pattern

Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990346BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp. · 1999-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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