DiaSorin Molecular LLC

Complete recall history across all FDA and CPSC categories — 8 total recalls

DiaSorin Molecular LLC 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 (8)

FDA medical device enforcement actions by DiaSorin Molecular LLC

Date Product Reason Class
Jun 14, 2023 Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A... There is a potential for the direct amplification disc to malfunction which ... Class II
Jan 30, 2023 Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE... Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may... Class II
Jan 30, 2023 Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;... Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may... Class II
Nov 19, 2021 Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 A subset of affected discs are at risk of leakage when it is used more than o... Class II
Sep 23, 2021 SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01)... Due to unapproved raw materials used in the manufacturing of Covid-19 contr... Class II
May 12, 2020 MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAIS... Due to a software malfunction in the Multi Assay Suite, there is the probabil... Class II
May 12, 2020 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous... Due to a software malfunction in the Multi Assay Suite, there is the probabil... Class II
May 12, 2020 MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the ... Due to a software malfunction in the Multi Assay Suite, there is the probabil... 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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