—#140892

Product

ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 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 product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K990346
Affected lot / code info: Software Version 1.0.3

Why it was recalled

Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.

Root cause (FDA determination)

Software design

Action the firm took

On October 7, 2015 Siemens Healthcare Diagnostics distributed Urgent Field Safety Notices to their custoemrs via Fed Ex in the U.S. and via email to regional countries for implementation outside of the U.S. Customers were provided a work-around if they have experienced any of the following problems: 1) Intermittent auto-startup function fails, 2) calibration interval resets as though a full calibration was performed, 3) Users may be unaware that the QC definition screen with +/- suggests a 2 Standard Deviation range value, 4) a rescanned and re-queried sample may become stuck in a communication loop and all tests may read as "inprocess" if the the initial reaction process is incomplete, 5) The printer stops printing if multiple printouts are requested in quick succession, 6) the ISE calibration for Urine Sodium (Na) may fail due to the ranges being set conservatively during development, 7) The automatic or manually started, archiving and deletion maintenance activity may fail and 8) A workstation services restart screen may appear under multiple scenarios causing the interface to be temporarily inaccessible. If customers have experienced any of the previously mentioned workflow problems, please perform the following actions: 1. Auto Start Failing: Manually perform the Startup Wash, run controls and any calibrations that are due. 2. Calibration interval resets when an RBL is run: Calibration should be run according to the recommendations in the Instructions for Use (IFU) for each assay. Keep a record of required calibrations and ensure that all assays are calibrated before use. 3. Control definition screen assumes that the range is defined as 2 SD values: When creating QC definitions, enter the values associated with a +/- 2 Standard Deviation (SD) range in the +/- ranges field.4. Laboratory Information System (LIS) communication / Laboratory Automation (LAS) issue: Be aware of errors in the event log and take action as needed. Manual intervention and rerunning

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.

Timeline

Recall initiated: 2015-10-07
Posted by FDA: 2016-02-04
Terminated: 2018-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.