Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch
Siemens Healthcare Diagnostics is recalling 572 ADVIA 2120i automated hematology analyzers 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 injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 572 units of the ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - 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 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 the analysis process. 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 for instructions on how to address the software 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.
The recalled product
- Product
- ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 572
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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
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 ADVIA 560 Hematology System Software Recall
FDA (Devices) · 2016-04-27
- HighSiemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- HighADVIA Hematology System Control Product Recall for Platelet Value Error
FDA (Devices) · 2025-07-09