Recall Z-1065-2015— SCC Soft Computer
Class II · Terminated
Class II FDA medical device recall by SCC Soft Computer, initiated 2014-11-26, terminated 2016-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0. Reason: Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database..
- Recalling firm
- SCC Soft Computer
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-26
- Terminated
- 2016-05-16
- Firm location
- Clearwater, FL, United States
Product description
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Reason for recall
Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.
Data sourced from openFDA. This site is unofficial and independent of the FDA.