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.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (missed diagnosis due to false negatives) where specific injury or illness reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
DiaSorin Molecular LLC is recalling 405 vials of the MOL3650 Simplexa VZV Direct test kit. This medical device is intended for use on the LIAISON MDX instrument to detect varicella-zoster virus (VZV) DNA in cerebrospinal fluid from patients with signs and symptoms of central nervous system infections.
The recall is being conducted due to a software malfunction in the Multi Assay Suite. This malfunction creates a probability of an increased occurrence of false negative results, which could lead to missed diagnoses of VZV infections.
The affected product was distributed worldwide, including nationwide in the United States and in Austria, the Czech Republic, France, and Switzerland. The specific lots involved are 5178N (released 06/12/19, expires 6/30/2020) and 7004N (released 03/04/20, expires 2/28/2021). Healthcare providers and laboratories should stop using these specific lots and contact the manufacturer for instructions on replacement or return.
The recalled product
- 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
- 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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