Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0433-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.

Product Classification:

Class II

Date Initiated: May 10, 2013

Date Posted: December 11, 2013

Recall Number: Z-0433-2014

Event ID: 65147

Reason for Recall:

Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

Status: Terminated

Product Quantity: 262

Code Information:

Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)

Distribution Pattern:

Worldwide Distribution: USA (nationwide) and internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated