EasyLink Data Management System recall: Software Issue
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic…
Why was EasyLink Data Management System recalled?
System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, and Sample reports.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers: 10444799, 10444800, 10487219
- Product
- EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1355
- Distribution
- Worldwide Distribution - US (nationwide) 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.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)