Qiagen EZ1 Advanced XL Recalled for Potential Heater Malfunction
Qiagen is recalling 298 EZ1 Advanced XL instruments due to a power board defect that may cause heater malfunctions and compromise nucleic acid extractions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect that compromises test results and causes delays rather than a direct risk of physical injury or death to the user. This aligns with a moderate severity rating for a professional medical device where the primary hazard is data integrity and workflow disruption.
Plain-English summary
Qiagen Sciences LLC is recalling 298 units of the EZ1 Advanced XL instrument (Model Number: 9001492, GTIN: 04053228010760). The recall is due to an issue with the power branching printed circuit board (PCB) that has the potential to trigger a heater malfunction.
If this failure occurs, nucleic acid extractions could be compromised, requiring the extractions to be repeated. This may cause a delay in obtaining results from downstream applications. The affected products were distributed worldwide, including in the United States and numerous foreign countries.
The instrument is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques. Users should check their instrument's serial number against the list of affected codes provided in the official recall notice to determine if their unit is included in this recall.
The recalled product
- 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…
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 298
Distribution
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