syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator

FDA device recall Z-2305-2012 · posted 2012-08-31 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Action taken

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

Status

Terminated

Product code

JQP

Quantity affected

44

Distribution

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.

Date initiated

2012-05-29

Date posted

2012-08-31

Date terminated

2014-04-10

Location

Newark, DE