Z-2548-2020 Class II Terminated
FDA device recall Z-2548-2020 was initiated by DiaSorin Molecular LLC on May 12, 2020 and is designated Class II. Reason for recall: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. The recall status is terminated (terminated April 19, 2024). Affected quantity: 405 plastic vials (24 vials per box).
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- May 12, 2020
- Termination Date
- April 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 405 plastic vials (24 vials per box)
Product Description
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).
Reason for Recall
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Distribution Pattern
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.
Code Information
MOL3650 Simplexa VZV Direct: Lot Numbers Release Date Exp Date 5178N 06/12/19 6/30/2020 7004N 03/04/20 2/28/2021