Recall Z-2548-2020 ยท PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
DiaSorin Molecular LLC
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).
| Date | Jul 10, 2020 (initiated May 12, 2020) |
| Status | Terminated |
| Reason | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| Root cause | Under Investigation by firm |
| Action | On 05/12/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION LETTER" with an acknowledgement form to customers and distributors via email to inform them of an internal observed issue associated with the use of their Multi-Assay Suite (MAS) featured in the software version 2.0 where it may incorrectly apply the thresholds of the first loaded assay to the analytes coupled with the same dye in the second assay resulting in false negative or false positive results. The firm is instructing customers to: -Immediately discontinue the use of the MAS feature and that the issue will be correct in |
| Quantity | 405 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack Diasorin Molecular, LLC, May 13, 2019 |