Manufacturer

DiaSorin Molecular LLC

8 recalls in our database name DiaSorin Molecular LLC as the manufacturing or recalling firm.

What the numbers show

Total: 8
Critical: 0
Severe: 0
Most recent: 2023-07-26

Of the 8 recalls from DiaSorin Molecular LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

HighFDA (Devices)·Z-2153-2023·2023-07-26
Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage
DiaSorin Molecular is recalling the Simplexa Direct Amplification Disc Kit due to potential malfunction that could cause liquid to spill from the device.
Product
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2023·2023-03-15
COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results
DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.
Product
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2023·2023-03-15
Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components
DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.
Product
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2022·2022-01-12
Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination
DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.
Product
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-0162-2022·2021-10-27
COVID-19 Diagnostic Control Pack Recalled for Unapproved Raw Materials
DiaSorin Molecular is recalling the SIMPLEXA COVID-19 Positive Control Pack due to unapproved raw materials in manufacturing that may cause delayed amplification signals during testing.
Product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2548-2020·2020-07-22
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2549-2020·2020-07-22
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2547-2020·2020-07-22
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
Medical Device
Distribution
Distributed nationwide