FDA recall Z-1195-2019

Product

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 for recall

Software Issues.

Distribution

Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.

Key facts

Status

Terminated

Initiation date

2015-08-26

Report date

2019-04-24

Termination date

2020-03-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1195-2019