Siemens ADVIA Chemistry System Software Recalled for Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software 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 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 an 'Urgent Medical Device Correction' for a diagnostic system, representing a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics has issued an urgent medical device correction for ADVIA 1650 System Software versions 4.01 and 3.52. The recall affects 892 units distributed in the United States and several international countries, including Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, and Vietnam.
The recall was initiated due to a defect in the ration parameters flagging behavior. This issue affects software versions utilized on ADVIA 1200, 1650, 1800, or 2400 Chemistry Systems. The software performs assays for general and specialty chemistries, specific protein measurement, drugs-of-abuse testing, and therapeutic drug monitoring.
Healthcare facilities using these systems should contact Siemens Healthcare Diagnostics for further instructions on correcting the software behavior. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- ADVIA 1650 System Software: 1) V4.01, 2) V3.52. 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
- 892
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 (2)
- Product Codes: 1) 10318424
- 2) 10285281
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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