Lower riskMedical device recall · FDA · Published March 31, 2021
SoftCytogenetics Software Recalled: Wrong Test Results Risk
Soft Computer Consultants recalls SoftCytogenetics software versions 4.1.11.20, 4:1.12.11, and 4.1.15.6 due to incorrect test results from reruns. Affected users should contact the company for details.
Software is given wrong results going out to HIS on test that had reruns.
Take action
Contact the company
📍Recalling firmSoft Computer Consultants, Inc.5400 Tech Data Dr · Clearwater, FL 33760-3116
✎ GovInfoNow plain-language explainer
Soft Computer Consultants has recalled specific versions of their SoftCytogenetics software because it provides incorrect test results when reruns are performed. This could lead to inaccurate medical decisions if the software is used for testing purposes. Read more at govinfonow.com/recall/62884-softcytogenetics-software-recalled-wrong-test-results-risk.
“SoftCytogenetics Software Recalled: Wrong Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62884-softcytogenetics-software-recalled-wrong-test-results-risk. Based on FDA recall #Z-2098-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2098-2021%22&limit=1).
Soft Computer Consultants, Inc. voluntarily recalled SoftCytogenetics software on March 31, 2021, according to the FDA. The software provides wrong results to hospital information systems for tests with reruns. Five units were distributed nationwide in California, Florida, Minnesota and New Jersey.
How to tell if you have it
Brand: Soft Computer Consultants
Product: SoftCytogenetics
Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
Quantity: 5 units
The hazard
The software gives wrong results going out to hospital information systems on tests that had reruns, according to the FDA.
Context
GovInfoNow's records show Soft Computer Consultants, Inc. has two other recalls on record since May 31, 2017. Other recent recalls of similar products include Exploro Fertility Test Recall (Nov. 22, 2025), Roche cobas pro integrated solutions recall (Jan. 20, 2026) and Siemens Atellica CH A1c_E Test Recall (June 8, 2026).
How to tell if you have this one
Check if you have SoftCytogenetics software versions 4.1.11.20, 4.1.12.11, or 4.1.15.6. The software is used for medical testing purposes.
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 specific instructions on how to handle the affected software versions.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of CA, FL, MN and NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Minnesota, New Jersey.
Recall timeline
FDA terminated this recall 23 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-2098-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2098-2021 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.