Qiagen EZ2 Connect MDx-IVD Recall: Heater Cable Failure May Cause Sample Loss
Qiagen recalls EZ2 Connect MDx-IVD molecular diagnostic devices due to heater cable issues that can cause sample loss. Affected models include 9003230 and many other serial numbers listed. No remedy specified in recall notice.
Lower-risk recall
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
Contact the company
What happened, in plain English
Qiagen is recalling EZ2 Connect MDx-IVD molecular diagnostic devices because insufficient welding causes heater cables to become brittle and may stop working, leading to sample loss. This affects users who perform nucleic acid testing and could result in failed tests if the device malfunctions. Read more at govinfonow.com/recall/55996-qiagen-ez2-connect-mdx-ivd-recall-heater-cable-failure-may.
Source Summary by GovInfoNow · govinfonow.com/recall/55996-qiagen-ez2-connect-mdx-ivd-recall-heater-cable-failure-may · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1508-2024
Cite this page
“Qiagen EZ2 Connect MDx-IVD Recall: Heater Cable Failure May Cause Sample Loss.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55996-qiagen-ez2-connect-mdx-ivd-recall-heater-cable-failure-may. Based on FDA recall #Z-1508-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1508-2024%22&limit=1).
Why it’s dangerous
The heater cable can become brittle due to insufficient welding, causing the device to display error code 3481 (heater unable to reach temperature). This may stop the device and result in lost samples during nucleic acid purification processes.
Who’s affected
Users of the EZ2 Connect MDx-IVD for nucleic acid testing in labs or research settings. Those with the specific model numbers listed in the recall are most at risk.
How to tell if you have this one
Check if your device has model number 9003230 or any of the many serial numbers listed in the recall notice. The device is designed for molecular diagnostic applications like nucleic acid purification.
- Brand
Qiagen- Product
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic- Category
Medical device
What to do — step by step
Check Device Model
Look for the model number on your EZ2 Connect MDx-IVD device to see if it matches the listed serial numbers in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1508-2024 (March 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1508-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.