ADVIA Chemistry XPT Systems recall: Software Issue
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral…
Why was ADVIA Chemistry XPT Systems 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version 1.0.3
- Product
- ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 87 units
- Distribution
- 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.
- Recall date
- February 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)