Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2173-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

Product Classification:

Class II

Date Initiated: June 7, 2012

Date Posted: August 15, 2012

Recall Number: Z-2173-2012

Event ID: 62403

Reason for Recall:

The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys

Status: Terminated

Product Quantity: 15

Code Information:

Version VA11B and all previously released versions.

Distribution Pattern:

USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated