Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493,…

Recall date

February 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1399-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.