Lower riskMedical device recall · FDA · Published March 31, 2021
SoftGenomics v4.1.15.6 Software Recall: Incorrect Results and PDF Mismatch
Soft Computer Consultants recalls SoftGenomics version 4.1.15.6 due to software showing wrong results and PDF mismatch with HIS. Affected users should contact for remedy.
“SoftGenomics v4.1.15.6 Software Recall: Incorrect Results and PDF Mismatch.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62875-softgenomics-v4-1-15-6-software-recall-incorrect-results-and. Based on FDA recall #Z-2093-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2021%22&limit=1).
The FDA announced on March 31, 2021, that Soft Computer Consultants, Inc. recalled SoftGenomics version 4.1.15.6 because the software may display incorrect results or generate PDFs that do not match hospital information systems. This voluntary Class II recall affects one unit distributed to California.
How to tell if you have it
Brand: Soft Computer Consultants
Product: SoftGenomics version 4.1.15.6
Distribution: CA only
The hazard
According to the FDA, the hazard involves software showing wrong results reported and PDFs not matching hospital information systems (HIS). The recall classification is Class II.
Context
GovInfoNow's records show Soft Computer Consultants, Inc. has two other recalls on record since May 31, 2017. On March 31, 2021, the firm recalled SoftCytogenetics Software due to a risk of wrong test results going out to HIS. On May 31, 2017, the company recalled SoftLab Software Lab System because of incorrect lab results risk from saved data sent to EMR systems. Other recent recalls of similar products include GE Healthcare Enterprise Archive V8 Software Recall (July 31, 2026), GE Healthcare Centricity PACS Software Recall (July 31, 2026), and GE Healthcare Workflow Core Services V8 Recall (July 31, 2026).
How to tell if you have this one
Check for the version number 4.1.15.6 on the software. The product is used in clinical laboratories for lab workflow management.
Brand
Soft Computer Consultants
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Soft Computer Consultants for guidance on the recall and next steps.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “US Distribution to: CA only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2093-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2093-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.