Recall Z-1942-2015 ยท JQP Calculator/Data Processing Module, For Clinical Use
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jun 30, 2015 (initiated Apr 29, 2015) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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. |
| Quantity | 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, New Zealand, Philippines, Portugal, Saudi-Arabia, Slovenia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.