Reported Aug 15, 2012 · Terminated
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data…
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 Drive, Mailstop 514 · Newark, DE · 19714-6101
Is this the product you have?
- EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
- Lot codes and dates
- Version 5.0 and Version 5.0 Service Pack 1 through 4
- Amount recalled
- 237
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following
This product could cause temporary or reversible health problems — stop using it.
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