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.
FDA Recall Z-2305-2012 · Posted 2012-08-31
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2012-05-29
Date Terminated2014-04-10
Product Quantity44
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
Firm Action
Siemens sent a Urgent Field Safety Notice letter dated May, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter instructed the customers to re-set the Multi-Rule option and instructions are provided on how to do so. This recall notification also included a Field Safety Effectiveness check form to please fax to the Siemens Technical Solutions Center at 302-631-8467 BY June 15th.
Root Cause
Software design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.