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.
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
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.
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.
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.
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.
Look for the model number on your EZ2 Connect MDx-IVD device to see if it matches the listed serial numbers in the recall.
The recall is due to insufficient welding in the heater cable, which can cause the device to display error 3481 (heater unable to reach temperature) and result in lost samples during nucleic acid purification.
The recall notice does not specify a remedy, so you should check if your device model is listed and contact Qiagen for further guidance.
The recall describes a risk of sample loss but does not mention any injury hazards, so there is no risk of injury.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-1508-2024 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-1508-2024 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
