ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493,

FDA device recall Z-1399-2015 · posted 2015-04-07 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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

Status

Terminated

Product code

JGS

Quantity affected

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.

Date initiated

2015-02-11

Date posted

2015-04-07

Date terminated

2017-03-02

Location

Tarrytown, NY

Related 510(k) clearances