FDA Enforcement
Class II
Terminated
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Recall: Z-1195-2019
·
Reported April 24, 2019
Enforcement
- Recall Number
- Z-1195-2019
- Event ID
- 82345
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2019
- Initiation Date
- August 26, 2015
- Classification Date
- April 18, 2019
- Termination Date
- March 24, 2020
- Address
- 500 Gbc Dr Ms 514, N/A, Newark, DE, 19702-2466, United States
Description
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Reason
Software Issues.
Code Info
Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt
Distribution
Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Quantity
449 systems