Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1944-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

Product Classification:

Class II

Date Initiated: May 20, 2014

Date Posted: July 9, 2014

Recall Number: Z-1944-2014

Event ID: 68394

Reason for Recall:

Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

Status: Terminated

Product Quantity: 336

Code Information:

syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B

Distribution Pattern:

Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated