Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2305-2012)

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:

syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device 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: May 29, 2012

Date Posted: September 12, 2012

Recall Number: Z-2305-2012

Event ID: 62709

Reason for Recall:

When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte

Status: Terminated

Product Quantity: 44

Code Information:

Version VA11B and all previously released versions.

Distribution Pattern:

USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.

Voluntary or Mandated:

Voluntary: Firm initiated