Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2547-2020 — MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs

U.S. FDA — Device Enforcement · United States · 2020-05-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2547-2020
Date of alert: 2020-05-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DiaSorin Molecular LLC
Product category: device
Product type: Devices

Reported risk: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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