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Terminated

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.

FDA Recall Z-0383-2019 · Posted None

Recalling FirmQiagen Sciences LLC
Recall StatusTerminated
Product CodeJJH
Date Initiated2018-07-23
Date Terminated2020-06-05
Product Quantity298

Reason for Recall

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.

Firm Action

The firm sent an Urgent Notice of Product Field Action letters dated July 23, 2018 to customers. The letter identified the affected product, problem and actions to be taken by the customer/user/commercial partner in order to assure that your instrument is currently functioning properly. Customers were asked to complete and sign the included Acknowledgement of Receipt form and either email it to QIAGEN Technical Service at [email protected] or fax it to +49 (0)2103-29-22400. For questions contact your local QIAGEN Technical Services Department.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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