Diasorin Inc.
Complete recall history across all FDA and CPSC categories — 6 total recalls
Diasorin 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 (6)
FDA medical device enforcement actions by Diasorin Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 7, 2024 | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the pr... | Customer complaints were received alleging leaking devices and insufficient b... | Class II |
| Dec 13, 2023 | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 | DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, ... | Class II |
| Nov 23, 2020 | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immun... | Potential for system to produce falsely elevated parathyroid hormone (PTH) re... | Class II |
| Jul 17, 2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Printed label inside the box lid of the Parvovirus has the incorrect Lot Spe... | Class II |
| Jul 13, 2016 | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol... | DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estr... | Class II |
| Mar 16, 2015 | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product ... | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely e... | 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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