Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch
Siemens Healthcare Diagnostics is recalling 195 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, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, as the hazard involves a potential sample identification error that could lead to incorrect patient results.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 195 units of the ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) automated hematology analyzer. The affected units are equipped with Software Versions 6.10 and 6.11. The recall is due to a potential sample identification (SID) mismatch when using 14-character barcodes.
The affected products were distributed worldwide, including across the United States and numerous international markets. The source text does not specify the exact number of units distributed in each specific country, only that the distribution pattern was worldwide and US nationwide.
Healthcare facilities and consumers who possess these specific analyzer units should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 195
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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