Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2173-2012

June 07, 2012

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 62403
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-2173-2012

Official wording

Reason: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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