—#118015

Product

syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.

FDA product code: NSX
Affected lot / code info: Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)

Why it was recalled

Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an Urgent Medical Device Correction letter in May 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the letter in its entirety and ensure that all operators understand the information presented. Specific actions needed to be implemented by the customer were outlined in the letter. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.

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: USA (nationwide) and internationally to Canada.

Timeline

Recall initiated: 2013-05-10
Posted by FDA: 2013-12-03
Terminated: 2014-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.