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.
Reported: July 22, 2020 Initiated: May 12, 2020 #Z-2549-2020
Product Description
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.
Reason for Recall
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Details
- Recalling Firm
- DiaSorin Molecular LLC
- Units Affected
- 304 plastic vials (24 vials per box)
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.
- Location
- Cypress, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DiaSorin Molecular LLC. Units affected: 304 plastic vials (24 vials per box).
Why was this product recalled? ▼
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2020. Severity: Moderate. Recall number: Z-2549-2020.
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