Siemens ADVIA 1200 Software Recalled for Ration Parameter Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1200 System Software versions 2.00 and 2.01 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 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 indicates a risk of temporary or medically reversible adverse health consequences. The source does not report specific injuries or illnesses, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics has issued an urgent medical device correction for ADVIA 1200 System Software versions 2.00 and 2.01. The recall involves 625 units of software that performs assays for general and specialty chemistries, specific protein measurement, drugs-of-abuse testing, and therapeutic drug monitoring.
The recall was initiated due to ration parameters flagging behavior issues in the software. This defect affects software versions utilized on ADVIA 1200, 1650, 1800, or 2400 Chemistry Systems. The affected software was distributed nationwide in the United States as well as in Sweden, Switzerland, Taiwan, Turkey, the United Kingdom, and Vietnam.
Healthcare facilities and users of the affected systems should contact Siemens Healthcare Diagnostics for further instructions on correcting the software behavior. The agency has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ADVIA 1200 System Software: 1) V2.00, 2) 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
- Affected units
- 625
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) 10386841
- 2) 10469445
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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