Nucleic Acid Isolation Device Recall: EZ2 Connect MDx-IVD Heater Failure
Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The manufacturing defect causes device malfunction and sample loss, creating risk to diagnostic testing without direct human harm. Per rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Qiagen Sciences LLC is recalling 168 units of the EZ2 Connect MDx-IVD automated nucleic acid isolation and purification device (Model Number 9003230). This device is designed to isolate and purify nucleic acids for molecular diagnostic and molecular biology applications.
A manufacturing defect involving insufficient welding has been identified in affected units. The defect causes the heater cable to become brittle, which leads to heater malfunction. When the heater fails, the device displays ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE and stops operating, resulting in loss of the sample being processed.
The recall affects 38 units distributed in the United States and 130 units distributed internationally in Austria, Australia, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, France, United Kingdom, Hungary, Italy, Jordan, Netherlands, Norway, Qatar, Saudi Arabia, Sweden, Slovenia, and Thailand.
The recalled product
- Product
- EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
- Manufacturer
- Qiagen Sciences LLC
- Category
- Medical Device
Distribution
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