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

Recall Z-1209-2023 — Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

U.S. FDA — Device Enforcement · United States · 2023-01-30 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1209-2023
Date of alert
2023-01-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DiaSorin Molecular LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20816101027020
Reported risk: Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
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.

Related

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.