Z-2093-2021Class II

SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be...

Name: Z-2093-2021 SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be...
Creator: Soft Computer Consultants, Inc.
Published: 2021-03-31
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2021-03-31 / Terminated / root cause: software

FDA source

Soft Computer Consultants, Inc. began a recall of SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics... on 2021-03-31. FDA classified it as Class II and gives the reason as "Software showing wrong results reported, PDF not match HIS". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2093-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Posted: 2021-07-19
Terminated: 2022-04-15
Recalling firm: SCC Soft Computer
Product: 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 code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software showing wrong results reported, PDF not match HIS.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm sent an " URGENT: MEDICAL DEVICE RECALL" letter dated 6/2/2021 to its sole consignee of the correction on 06/02/2021 by mail. The letter described the product, problem and actions to be taken. The consignee was instructed to do the following: Acknowledge receipt of this letter in the TMS task Give permission to load Hot Fix on Test environment Perform validation activities to completion Acknowledge Hot Fix has been moved to Live environment and is working as expected Type of action by Company: All clients on affected lines of software have been notified of the recall. SCC will provide Hot Fixes for all affected lines that will be delivered to all affected clients. Until the software correction is delivered, clients have been informed of an alternative workflow to avoid the problem. The firm provided information on a software update performed on 03/31/2021 and stated that, "Hot Fix has already been delivered." If you have any further questions, Please call 1-800-763-8522 (Technical Support 24/7).
Quantity in commerce: 1
Distribution: US Distribution to: CA only
Product codes and lots: Version 4.1.15.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2093-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2093-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)