Recall Z-0383-2019— Qiagen Sciences LLC

Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2018-07-23, terminated 2020-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.. Reason: 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..

Recalling firm

Qiagen Sciences LLC

Classification

Class II

Status

Terminated

Initiated

2018-07-23

Terminated

2020-06-05

Firm location

Germantown, MD, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.