Siemens ADVIA Chemistry System Software Recalled for Parameter Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1800 System Software V2.01 due to ration parameters flagging behavior issues.
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, which typically corresponds to a High severity score when no specific hospitalizations or injuries are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics has issued an urgent medical device correction for ADVIA 1800 System Software V2.01. This software performs assays for general and specialty chemistries, specific protein measurement, drugs-of-abuse testing, and therapeutic drug monitoring.
The recall is due to ration parameters flagging behavior affecting all software versions utilized on ADVIA 1200, 1650, 1800, or 2400 Chemistry Systems. A total of 1,366 units are affected by this correction.
The affected units were distributed nationwide in the United States and in Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, and Vietnam. Users of these systems should contact Siemens Healthcare Diagnostics for further instructions regarding the software correction.
The recalled product
- Product
- ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
- Manufacturer
- Siemens Healthcare Diagnostics
- Hazard
- Affected units
- 1,366
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: 10639244
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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