The Recall Desk

FDA (Devices) recall action 85744

DiaSorin Molecular LLC recalled 3 products on 2020-07-22

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-07-22
Critical
0
Units
—

Why these products were recalled

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2020-07-22

    DiaSorin Simplexa HSV 1&2 Direct Recalled Due to Software Malfunction

    DiaSorin Molecular LLC is recalling Simplexa HSV 1&2 Direct test kits because a software malfunction may cause false negative results.

    Product
    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocut
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2020-07-22

    DiaSorin Simplexa VZV Swab Direct Recalled for Software Malfunction

    DiaSorin Molecular LLC is recalling Simplexa VZV Swab Direct kits due to a software malfunction that may cause false negative results.

    Product
    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2020-07-22

    DiaSorin Simplexa VZV Direct Recalled for Potential False Negative Results

    DiaSorin Molecular LLC is recalling Simplexa VZV Direct test kits due to a software malfunction that may cause false negative results for varicella-zoster virus.

    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
    Category
    Distribution
    9 states