Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch
Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers 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, and the hazard involves a risk of harm (incorrect sample identification) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 283 units of the ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - 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 issued 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 users of the affected devices should contact Siemens Healthcare Diagnostics for further instructions on how to address the software issue. No specific instructions for end-consumers are provided as this is a professional medical device.
The recalled product
- Product
- ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 283
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.
See all 20 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
Similar recalls
- HighSiemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk
FDA (Devices) · 2013-10-23
- HighSiemens ADVIA 560 Hematology Systems Recalled for Incorrect Results
FDA (Devices) · 2016-12-14
- HighSiemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- HighSiemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- HighSiemens RAPIDLab 1260 Blood Gas Analyzer Recalled for Data Mismatch
FDA (Devices) · 2016-09-21
- HighSiemens ADVIA 560 Hematology System Software Recall
FDA (Devices) · 2016-04-27