Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk
Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics is recalling ADVIA 2120/2120i Hematology Systems that are connected to an ADVIA Autoslide. The recall involves 311 units total, with 51 units in the United States and 260 units distributed worldwide to countries including Australia, Austria, Belgium, Canada, and the United Kingdom.
Siemens determined that if an autosampler rack jam error occurs during operation, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information. This mislabeling could lead to incorrect patient results.
The affected units are identified by serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide. Siemens is the recalling firm. The source text does not specify specific corrective actions for consumers or healthcare providers, such as software updates or hardware replacements.
The recalled product
- Product
- ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry…
- Manufacturer
- Siemens Healthcare Diagnostics
- Hazard
Distribution
Distributed nationwide across the United States.
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