—#136533

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 Solutions.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Catalog Numbers: 10444799, 10444800, 10487219

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.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an Urgent Field Safety Notice (UMDC # ISW-15-01.A.US) on May 5, 2015 to all affected customers. The letter instructed customers to follow specific work around instructions, review this letter with their Medical Director, complete and return the Field Correction Effectiveness Check attached to this letter within 30 days, retain the letter with laboratory records, and forward it to those who may have received this product. For questions regarding this recall call 800-441-9250.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-04-29
Posted by FDA: 2015-06-30
Terminated: 2017-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136533. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.