Recalls / —
—#171402
Product
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
- FDA product code
- JQP — Calculator/Data Processing Module, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt
Why it was recalled
Software Issues.
Root cause (FDA determination)
Device Design
Action the firm took
Siemens mailed an Urgent Field Safety Notice and an Urgent Field Correction Letter to affected customers on 08/26/2015 to inform them of the issue. The reason for the correction, risk to health and actions to be taken were explained in the notice.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Timeline
- Recall initiated
- 2015-08-26
- Terminated
- 2020-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #171402. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.