DiaSorin Molecular LLC recalls
Every recall we track for DiaSorin Molecular LLC — 8 in all, from 2020–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
8 recalls since 2017.
All FDA recall records for DiaSorin Molecular LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 3 | 0 | 3 |
| 2021 | 0 | 1 | 1 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 2 | 0 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled DiaSorin Molecular LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All DiaSorin Molecular LLC recalls
5 shown- Lower riskMedical device
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box
DiaSorin recalls Simplexa Direct Amplification Disc Kit (Rx Only) due to potential liquid spillage from malfunctioning discs. Affected units include specific lot codes and reference numbers.
DiaSorinJun 14, 2023 - Use cautionMedical device
DiaSorin Molecular LLC recalls Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
DiaSorin recalls Simplexa COVID-19 Direct test kits with specific lot numbers due to potential leakage and cross-contamination risks, leading to invalid results and error codes.
DiaSorinJan 30, 2023 - Use cautionMedical device
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
DiaSorin recalls Simplexa Direct Amplification Disc Kit (MOL1455) due to potential leakage when reused, risking lab cross-contamination. Affected lots listed in product details.
DiaSorinNov 19, 2021 - Lower riskMedical device
DiaSorin Molecular LLC recalls SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
DiaSorin recalls SIMPLEXA COVID-19 Positive Control Packs with unapproved materials that may cause delayed amplification signals. Affected units include specific lot numbers and expiration dates.
DiaSorinSep 23, 2021 - Lower riskMedical device
DiaSorin Molecular LLC recalls MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative
DiaSorin recalls MOL3655 Simplexa VZV Swab Direct for potential false negative results from a software malfunction in the Multi Assay Suite. Affected lots were sold between September 2019 and February 2021.
DiaSorinMay 12, 2020
DiaSorin Molecular LLC recall questions
How many recalls has DiaSorin Molecular LLC had?
8 recalls from DiaSorin Molecular LLC are on record with U.S. safety agencies, from 2020–2023.
What is the most recent DiaSorin Molecular LLC recall?
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box, dated Jun 14, 2023. Every DiaSorin Molecular LLC recall is listed on this page, newest first.
What should I do if I have a recalled DiaSorin Molecular LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new DiaSorin Molecular LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.