Soft Computer Consultants, Inc. Recall 88095
Description: 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 knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
Soft Computer Consultants, Inc. Recall 88095 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2093-2021 |
| Event ID | 88095 |
| Event Description | 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 knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting. |
| Product Type | Devices |
| Distribution | US Distribution to: CA only |
| Quantity | 1 |
| Recall Reason | Software showing wrong results reported, PDF not match HIS. |
| Device Classification | 20210728 |
| Device Code Info | Version 4.1.15.6 |
| Center Classification Date | 20210719 |
| Recall Initiation Date | 20210331 |
| Recalling Firm | Soft Computer Consultants, Inc. |
| Initial Notification | Letter |
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