Reported Jul 8, 2015 · Terminated
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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 Solutions.
- Lot codes and dates
- Catalog Numbers
104447991044480010487219
- Catalog Numbers
- Amount recalled
- 1355
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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