—#110694

Product

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.

FDA product code: NSX
Affected lot / code info: Version 5.0 and Version 5.0 Service Pack 1 through 4

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

Root cause (FDA determination)

Software design

Action the firm took

The firm initiated this recall on June 7, 2012 by issuing an "Urgent Field Safety Notice" to all customers who are known to have the EasyLink system and who also own and operate Sysmex CA-1500 and CA-7000 instruments. The Notice described the problem and provided recommended actions. Customers can contact 800-441-9250 for questions.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail.

Timeline

Recall initiated: 2012-06-07
Posted by FDA: 2012-08-09
Terminated: 2014-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110694. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.