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.
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, and the hazard involves false negative results for a serious infection (HSV), which poses a risk of harm where injury has not yet been reported.
Plain-English summary
DiaSorin Molecular LLC is recalling the MOL2150 Simplexa HSV 1&2 Direct test kits. The recall involves 13,943 plastic vials (24 vials per box) distributed nationwide in the United States and in Austria, the Czech Republic, France, and Switzerland.
The recall was initiated due to a software malfunction in the Multi Assay Suite. This malfunction creates a probability of an increased occurrence of false negative results for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid or cutaneous and mucocutaneous lesion swabs.
Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact DiaSorin Molecular LLC for instructions on return or replacement. The affected lots include various release dates ranging from 2018 to 2020, with expiration dates extending into 2022.
The recalled product
- 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
- 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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