MOL3650 Simplexa VZV Direct — Class II medical device recall Z-2548-2020
Terminated recall by DiaSorin Molecular LLC, reported 2020-07-22, distributed nationwide. Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of fa
| Recall number | Z-2548-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DiaSorin Molecular LLC, Cypress, CA, United States |
| Recall initiated | 2020-05-12 |
| Classified | 2020-07-10 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2024-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CZ, FR |
| Reason classes | potency, device malfunction, software |
Product
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).
Reason for recall
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2548-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.