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

Recall Z-1508-2024 — EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

U.S. FDA — Device Enforcement · United States · 2024-03-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1508-2024
Date of alert
2024-03-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Qiagen Sciences LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04053228040576
Reported risk: Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.