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

Recall Z-0383-2019 — EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for t

U.S. FDA — Device Enforcement · United States · 2018-07-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0383-2019
Date of alert
2018-07-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Qiagen Sciences LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04053228010760
Reported risk: An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
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.