15

Apr

2015

Cl II Siemens ADVIA Chemistry XPT System

0

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 4/15/2015
Class lI:

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.
Recall Number Z-1399-2015

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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc,Tarrytown, NY on 2/11/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
16 units

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

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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