Qiagen recalls QIAcube Connect MDx (Model 9003070) due to incorrect volume guidance during sample loading, which may cause false negative or positive test results. Affected units have specific serial numbers listed in the recall notice.
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Qiagen is recalling QIAcube Connect MDx devices with model number 9003070 because the device shows the wrong volume during sample loading steps. This could lead to inaccurate test results, such as false negatives or positives, if users misunderstand the guidance.
The device displays 'minimal volume to be loaded' but shows the exact volume that should be loaded, not the minimal amount. This misunderstanding can cause samples to be over-diluted, under-diluted, or improperly lysed, leading to false negative or positive test results.
Users of QIAcube Connect MDx devices for laboratory testing who own the recalled model (9003070) with specific serial numbers listed in the recall notice. Laboratory technicians and researchers using these devices are most at risk of inaccurate test results.
Check if your QIAcube Connect MDx has model number 9003070 and serial numbers listed in the recall notice (e.g., 30000-30145). The device is sold for laboratory use and may be used in medical testing environments.
Verify your QIAcube Connect MDx has model number 9003070 and the specific serial numbers listed in the recall notice.
The device shows the wrong volume during sample loading steps, which may cause false negative or positive test results if users misunderstand the guidance.
Check if your device has model number 9003070 and the specific serial numbers listed in the recall notice. No action is required beyond verifying your device model and serial numbers.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-1746-2022 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-1746-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
