Device 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).
Z-2548-2020
Product summary
- Event
- Event 85744
- Status
- Terminated
- Classification
- Class II
- Quantity
- 405 plastic vials (24 vials per box)
- Official record key
device-enforcement:Z-2548-2020
Official wording
Reason: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
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
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.
Derived failure modes
-
Device software or design
software malfunction