Siemens ADVIA Chemistry XPT Systems Recalled for Multiple Software Issues
Siemens Healthcare Diagnostics is recalling 87 ADVIA Chemistry XPT Systems due to software defects that may cause test failures, calibration errors, and system restarts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes software defects that could affect test accuracy or system operation but does not report any specific injuries, illnesses, or fatalities. Therefore, it falls under the Moderate category as a precautionary recall for a medical device with potential for temporary adverse health consequences.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 87 units of ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538. These clinical chemistry analyzers are used to run tests on serum, plasma, urine, or cerebral spinal fluid. The recall is due to multiple software issues, including auto start-up failures, calibration interval resets, and incorrect control definition ranges.
Additional software defects include issues with Laboratory Information System (LIS) communication, printer driver resets, and overly conservative ISE calibration ranges for urine sodium. The software may also fail to archive or delete data correctly, and workstation services may restart unexpectedly. These issues could affect the accuracy of test results or the operation of the laboratory equipment.
The affected units were distributed worldwide, including in the United States (AZ, CA, MA, NY, TX, WA) and in Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic of Korea, Netherlands, Denmark, Finland, and the United Kingdom. Siemens Healthcare Diagnostics is the recalling firm. Users should contact Siemens for further instructions on how to address these software issues.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 87
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version 1.0.3
Distribution
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