Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors
Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incorrect clinical test results) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry XPT Chemistry Systems (SMN 10723034) due to a potential defect in the Ion-Selective Electrode (ISE) module. The recall affects 15 domestic units and 59 foreign units distributed worldwide, including in the United States, Australia, and various European and Asian countries.
The ISE module may produce discrepant, unflagged results for Sodium, Potassium, or Chloride if the respective electrode is left unplugged after replacement, washing, or maintenance. While the calibration and two-level quality control (QC) will fail if the electrode is unplugged, the system may still report patient results without flagging the error if the user does not strictly follow the instructions for use (IFU) to calibrate and run controls before testing patient samples.
Healthcare facilities should contact Siemens Healthcare Diagnostics for instructions on how to address this issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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)
- All serial numbers
Distribution
Distribution scope not specified by the agency.
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