Recall Z-1944-2014— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-05-20, terminated 2015-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.. Reason: 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-20
- Terminated
- 2015-08-10
- Firm location
- Newark, DE, United States
Product description
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.