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.

Recall Insight

This FDA Devices action (record #Z-2549-2020) was formally reported on July 22, 2020, with the manufacturer initiating the action on May 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. DiaSorin Molecular LLC is listed as the recalling firm, operating out of Cypress, CA. Federal records indicate 304 plastic vials (24 vials per box) units are affected.

The documented reason for this recall is: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.