Soft Computer Consultants, Inc.
Complete recall history across all FDA and CPSC categories — 5 total recalls
Soft Computer Consultants, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (5)
FDA medical device enforcement actions by Soft Computer Consultants, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 31, 2021 | SoftCytogenetics | Software is given wrong results going out to HIS on test that had reruns. | Class II |
| Mar 31, 2021 | SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and in... | Software showing wrong results reported, PDF not match HIS. | Class II |
| May 31, 2017 | SoftLab Software Laboratory information system to be used in a medical res... | Display of lab results based on incorrect LOINC code/test descriptions for te... | Class II |
| Oct 6, 2016 | Softbank software Product Usage: Decision support software for transfusio... | Software error. Potential for incorrect results | Class II |
| Oct 6, 2016 | SCC Soft Computer Softbank II software Product Usage: Supports single and... | Software error. Potential for incorrect results | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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