Clearwater, FL, United States
Soft Computer Consultants, Inc. recalls
2 recalls recorded since 2018, most recently on 31 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 31 March 2021
- Terminated
- 15 April 2022
- Reason
- Software showing wrong results reported, PDF not match HIS.
- Distribution
- US Distribution to: CA only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2093-2021
- SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeab
Terminated Class II Medical devices
- Recall started
- 31 March 2021
- Terminated
- 14 February 2023
- Reason
- Software is given wrong results going out to HIS on test that had reruns.
- Distribution
- US Nationwide Distribution in the states of CA, FL, MN and NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2098-2021
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.