Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch Risk
Siemens is recalling 1,452 ADVIA 2120i Dual Aspirate Autosamplers worldwide due to a potential sample identification mismatch with 14-character barcodes.
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 a sample identification error could lead to incorrect patient results, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,452 units of the ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The product was distributed worldwide, including the United States and numerous international markets.
The recall is being conducted because of a potential Sample Identification (SID) mismatch when using 14-character barcodes. This issue could lead to incorrect sample identification during automated hematology analysis.
Healthcare facilities and laboratories that have purchased or received these specific units should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action for end-users, as the product is intended for professional medical use.
The recalled product
- Product
- ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,452
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)
- Software Versions 6.10 and 6.11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Siemens Healthcare Diagnostics, Inc. 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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