Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch
Siemens is recalling 43 ADVIA 2120 automated hematology analyzers 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 is classified as FDA Class II. The hazard involves a potential sample identification mismatch, which is a risk-of-harm product issue where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 43 units of the ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The devices were distributed worldwide, including the United States and numerous international locations.
The recall is issued because of a potential Sample Identification (SID) mismatch with 14-character barcodes. This issue could result in incorrect sample identification during automated processing. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users of these devices should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 43
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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