Siemens EasyLink Data Management System Recalled for Software Limitations
Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes software limitations without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,355 units of the EasyLink Data Management System. 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 is due to system limitations and software issues related to custom reference ranges, user-initiated sample and result actions, auto-verification and quality control rules, and sample reports. The affected units were distributed nationwide in the United States and internationally to Austria, Belgium, Canada, Switzerland, Germany, Denmark, Spain, France, Hong Kong, Italy, Japan, Korea, Malaysia, Netherlands, Norway, New Zealand, Philippines, Portugal, Saudi-Arabia, Slovenia, and Taiwan.
The affected products have catalog numbers 10444799, 10444800, and 10487219. Users should contact Siemens Healthcare Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,355
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)
- Catalog Numbers: 10444799
- 10444800
- 10487219
Distribution
Distributed nationwide across the United States.
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