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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where injury has not yet been reported, fitting the 'High' severity criteria for potential adverse health consequences due to false negatives.
Plain-English summary
DiaSorin Molecular LLC is recalling the Simplexa VZV Swab Direct product, a medical device intended for the qualitative detection of varicella-zoster virus (VZV) DNA in cutaneous and mucocutaneous lesion swabs. The recall is being conducted due to a software malfunction in the Multi Assay Suite.
The malfunction creates a probability of an increased occurrence of false negative results. This means that some patients with VZV infection may be incorrectly identified as negative, potentially affecting clinical decision-making.
The affected product is distributed worldwide, including in the United States and in Austria, Czech Republic, France, and Switzerland. Specific lot numbers and expiration dates are listed in the official recall notice. Healthcare providers and laboratories should stop using the affected lots and contact the manufacturer for instructions on returns or replacements.
The recalled product
- 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.
- Manufacturer
- DiaSorin Molecular LLC
Distribution
Part of a larger recall action
This product is one of 3 recalled by DiaSorin Molecular LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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