Recall Z-2549-2020 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
DiaSorin Molecular LLC
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.
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack Diasorin Molecular, LLC, Nov 26, 2019 |