EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with pr
FDA device recall Z-1942-2015 · posted 2015-06-30 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 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, N
- Date initiated
- 2015-04-29
- Date posted
- 2015-06-30
- Date terminated
- 2017-05-11
- Location
- Newark, DE
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