—#111471

Product

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 product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Version VA11B and all previously released versions.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

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.

Timeline

Recall initiated: 2012-05-29
Posted by FDA: 2012-08-31
Terminated: 2014-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.