Z-2093-2021 Class II Terminated
FDA device recall Z-2093-2021 was initiated by Soft Computer Consultants, Inc. on March 31, 2021 and is designated Class II. Reason for recall: Software showing wrong results reported, PDF not match HIS. The recall status is terminated (terminated April 15, 2022). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- March 31, 2021
- Termination Date
- April 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product 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.
Reason for Recall
Software showing wrong results reported, PDF not match HIS.
Distribution Pattern
US Distribution to: CA only
Code Information
Version 4.1.15.6