FDA-Device2018-11-14Class II
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
Qiagen Sciences LLC
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Australia, Austria, Canada, China, Dubai, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Korea, Latvia, Mexico, Morocco, Norway, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, UK.
Affected count
298
Manufactured in
19300 Germantown Rd, Germantown, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0383-2019Don't want to check this manually?
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