Siemens ADVIA Chemistry System Software Recalled for Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 2400 System Software V4.01 due to incorrect ration parameter flagging behavior.
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 does not report any specific injuries, illnesses, or fatalities, and the defect is a software flagging error rather than a direct physical hazard like fire or shock.
Plain-English summary
Siemens Healthcare Diagnostics has issued an urgent medical device correction for the ADVIA 2400 System Software V4.01. This software is used on ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems to perform assays for general and specialty chemistries, specific protein measurement, drugs-of-abuse testing, and therapeutic drug monitoring.
The recall is due to a defect in the ration parameters flagging behavior across all software versions utilized on these systems. The issue affects 876 units of the software.
The affected products were distributed nationwide in the United States as well as in Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, and Vietnam. Users of these systems should contact Siemens Healthcare Diagnostics for further instructions regarding the correction.
The recalled product
- Product
- ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
- Manufacturer
- Siemens Healthcare Diagnostics
- Affected units
- 876
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)
- Product Code: 10639265
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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