Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors
Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.
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 medical device with a risk of harm (incorrect result transmission) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Siemens EasyLink Informatics System V4.0/V5 (Material Numbers 10444799, 10444800, 10487219). This clinical data management system assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS), and Siemens StreamLAB Automation Solutions.
The recall was initiated because the system may not perform as intended under certain conditions. Specifically, it may cause the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules, or it may delay or omit the transmission of results to the LIS.
The recall covers 1,347 units distributed nationwide in the United States. The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,347
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 (3)
- EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799
- 10444800
- 10487219
Distribution
Distributed nationwide across the United States.
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 · data integrity
See all →- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSiemens EasyLink Data Management System Recalled for Software Limitations
FDA (Devices) · 2015-07-08
- HighSiemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results
FDA (Devices) · 2012-08-15
- HighSiemens EasyLink Informatic System Recalled for Quality Control Defect
FDA (Devices) · 2012-08-29
- HighSiemens CentraLink Software Recall for Potential Patient Data Release Error
FDA (Devices) · 2014-01-29
- HighSiemens CentraLink Software Recalled for Potential Erroneous Patient Results
FDA (Devices) · 2020-07-08
- ModerateSiemens CentraLink Data Management System Software Recall
FDA (Devices) · 2015-07-08