Recall Z-0433-2014 ยท NSX
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Dec 3, 2013 (initiated May 10, 2013) |
| Status | Terminated |
| Reason | 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 | Software design |
| Action | 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 instr |
| Quantity | 262 |
| Distribution | Worldwide Distribution: USA (nationwide) and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.