—#127507

Product

syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B

Why it was recalled

Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

Root cause (FDA determination)

Device Design

Action the firm took

An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.

Timeline

Recall initiated: 2014-05-20
Posted by FDA: 2014-06-30
Terminated: 2015-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127507. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.