Lower risk Medical device recall · FDA · Published November 21, 2021

Qiagen QIAcube Connect MDx Model 9003070: Incorrect Volume Guidance May Cause False Test

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1746-2022Medical device Qiagen ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmQiagen Sciences LLC19300 Germantown Rd · Germantown, MD 20874-1415

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61512-qiagen-qiacube-connect-mdx-model-9003070-incorrect-volume-guidance-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61512-qiagen-qiacube-connect-mdx-model-9003070-incorrect-volume-guidance-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1746-2022

Cite this page

“Qiagen QIAcube Connect MDx Model 9003070: Incorrect Volume Guidance May Cause False Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61512-qiagen-qiacube-connect-mdx-model-9003070-incorrect-volume-guidance-may. Based on FDA recall #Z-1746-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1746-2022%22&limit=1).

The FDA announced on Nov. 21, 2021, that Qiagen Sciences LLC is recalling QIAcube Connect MDx devices due to a software error that may cause false test results. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Qiagen
Product: QIAcube Connect MDx
Model No.: 9003070
UDI-DI (GTIN): 04053228039129
Serial Numbers: 30000, 30009, 30027, 30039, 30049, 30061, 30073, 30002, 30010, 30028, 30041, 30050, 30062, 30075, 30003, 30132, 30031, 30042, 30051, 30063, 30078, 30004, 30013, 30032, 30043, 30053, 30064, 30080, 30005, 30016, 30034, 30044, 30057, 30065, 30082, 30006, 30019, 30035, 30045, 30058, 30067, 30089, 30007, 30021, 30033, 30046, 30059, 30069, 30090, 30008, 30023, 30037, 30047, 30060, 30071, 30093, 30094, 30095, 30097, 30102, 30104, 30109, 30112, 30114, 30115, 30117, 30118, 30119, 30121, 30124, 30127, 30128, 30129, 30130, 30131, 30133, 30134, 30136, 30138, 30139, 30140, 30141, 30143, 30145, 30106, 30025, 30077, 30054, 30055, 30066, 30076

The hazard

GovInfoNow's records show that during the "Load tip racks and enzymes" step, the device screen incorrectly indicates a minimal volume instead of the exact required volume. This misunderstanding may lead to over-diluted, under-diluted, or improperly lysed samples, which could result in false negative or false positive results.

Context

GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Other recent recalls of similar products include Qiagen QIAstat-Dx Respiratory Panel Plus (March 12, 2025) and Qiagen QIAcube Connect MDx (June 3, 2024).

How to tell if you have this one

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.

Brand
Qiagen
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Verify your QIAcube Connect MDx has model number 9003070 and the specific serial numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 25 states and D.C., and outside the U.S.

FDA distribution: “Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Minnesota, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 10 months after the firm started it.

Nov 21, 2021Firm started the recall
Sep 15, 2022FDA classified it Class II
Sep 21, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Qiagen recalls

Link to this recall

<a href="https://govinfonow.com/recall/61512-qiagen-qiacube-connect-mdx-model-9003070-incorrect-volume-guidance-may">Qiagen QIAcube Connect MDx Model 9003070: Incorrect Volume Guidance May Cause False Test (GovInfoNow)</a>

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-1746-2022 (November 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1746-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.