Siemens ADVIA 120 Hematology Analyzer Recall for Optics Cover Failure
Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.
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 (falling heavy cover) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the ADVIA 120 Hematology Analyzer, catalog numbers SMN 10360958 and 10360959. The recall involves 950 units distributed in the United States and 3,369 units distributed in various foreign countries, including Austria, Australia, and the United Kingdom.
The recall is due to a defect in the gas struts that support the optics cover on top of the analyzer. Over time, these struts may lose effectiveness and fail to hold the cover in the open position. This failure could cause the cover to fall during maintenance procedures.
Users of the affected devices should contact Siemens Healthcare Diagnostics for instructions on how to address the issue. The recall covers all serial numbers for the specified catalog numbers.
The recalled product
- Product
- ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
- Manufacturer
- Siemens Healthcare Diagnostics
- Hazard
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics
See all →- ModerateSiemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
FDA (Devices) · 2018-03-07
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
FDA (Devices) · 2014-09-24
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighSiemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk
FDA (Devices) · 2013-10-23
- HighSiemens ADVIA Centaur XP Immunoassay System Recalled for Gas Spring Failure
FDA (Devices) · 2014-05-14
- HighSiemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch
FDA (Devices) · 2021-04-21
- HighSiemens ADVIA 560 Hematology System Software Recall
FDA (Devices) · 2016-04-27
- HighSiemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch
FDA (Devices) · 2021-04-21
- ModerateADVIA Hematology Control Recalled for Incorrect Platelet Value Assignments
FDA (Devices) · 2025-07-09