SoftLab Software Lab System Recall: Incorrect Lab Results Risk
SoftLab Software versions 4.5.4.3-4.5.5.20 recalled for incorrect lab result display due to LOINC code errors. Affected medical labs must stop using these versions immediately.
Recall notice
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
Contact the company
What happened, in plain English
SoftLab Software versions 4.5.4.3 through 4.5.5.20 are recalled because they display lab results using incorrect LOINC codes, which could lead to wrong medical information being shown. This affects medical research and clinical labs that use these software versions. Read more at govinfonow.com/recall/73999-softlab-software-lab-system-recall-incorrect-lab-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73999-softlab-software-lab-system-recall-incorrect-lab-results-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2865-2017
Cite this page
“SoftLab Software Lab System Recall: Incorrect Lab Results Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73999-softlab-software-lab-system-recall-incorrect-lab-results-risk. Based on FDA recall #Z-2865-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2865-2017%22&limit=1).
Why it’s dangerous
The software incorrectly displays lab results when tests from reference labs are saved with wrong LOINC codes. This means medical information could be displayed incorrectly in the electronic medical record system, potentially causing errors in patient care.
Who’s affected
Medical research and clinical labs using the recalled software versions are most at risk. Knowledgeable, trained personnel who operate these systems may be affected.
How to tell if you have this one
Check if you have SoftLab Software versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, or 4.5.5.20. These versions are used in medical research or clinical laboratories.
- Brand
Soft Computer Consultants- Category
Medical device
What to do — step by step
Check Software Version
Identify your software version by checking the version numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 11 states.
FDA distribution: “US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2865-2017 (May 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2865-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.