Z-1942-2015Class II

EasyLink Data Management System; a clinical data management system that assists medical laboratory...

Name: Z-1942-2015 EasyLink Data Management System; a clinical data management system that assists medical laboratory...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-04-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-04-29 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions... on 2015-04-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1942-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-29
Posted: 2015-06-30
Terminated: 2017-05-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Catalog Numbers: 10444799, 10444800, 10487219

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1942-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1942-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-30

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)