Lower risk Medical device recall · FDA · Published June 3, 2024

Qiagen QIAcube Connect MDx Recall: Heater Shaker Module May Cause Delayed Results

Qiagen recalls QIAcube Connect MDx instruments with heater shaker modules that may not heat below 40°C, causing delayed or erroneous DNA results. Affected units have serial numbers 30000-30506.

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

🇺🇸 FDA recall #Z-2353-2024Medical device Qiagen ›

Lower-risk recall

Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Qiagen is recalling QIAcube Connect MD: heater shaker modules may not heat properly below 40°C when using specific DNA extraction kits, which could lead to delayed or incorrect test results. This affects lab equipment used for DNA testing in medical and research settings. Read more at govinfonow.com/recall/54934-qiagen-qiacube-connect-mdx-recall-heater-shaker-module-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/54934-qiagen-qiacube-connect-mdx-recall-heater-shaker-module-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2353-2024

Cite this page

“Qiagen QIAcube Connect MDx Recall: Heater Shaker Module May Cause Delayed Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54934-qiagen-qiacube-connect-mdx-recall-heater-shaker-module-may-cause. Based on FDA recall #Z-2353-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2353-2024%22&limit=1).

The FDA announced on June 3, 2024, that Qiagen Sciences LLC is recalling QIAcube Connect MDx instruments because the heater shaker module may fail to heat properly. This defect could cause delayed or erroneous test results for users of specific IVD protocols. Owners should contact the company for information.

How to tell if you have it

Brand: Qiagen
Product: QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in
Catalog Number: 900370
Software Version: 1.0.1
GTIN: 04053228039129
Serial Numbers: SN 30000-30506
Quantity: 419 units

The hazard

The heater shaker module does not perform heating if the temperature is set below 40°C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304). This malfunction could potentially cause delayed or erroneous results depending on the downstream assay, according to the FDA.

Context

GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Recent similar recalls include the QIAstat-Dx Respiratory Panel Plus recall on March 12, 2025, and the EZ2 Connect MDx-IVD Recall on March 4, 2024. Other recent recalls of similar products include the Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026) and Medline Convenience Kits Recalls (May 28, 2026).

How to tell if you have this one

Check if your QIAcube Connect MDx has a serial number between 30000 and 30506. The instrument was sold with software version 1.0.1 and GTIN 04053228039129.

Brand
Qiagen
Product
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your QIAcube Connect MDx has a serial number between 30000 and 30506.
Review Protocol Instructions
Ensure you are using the QIAamp DSP DNA Mini Kit (cat. no. 61304) with the specific protocol for Gram-positive bacteria DNA extraction.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI” 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 51 days after the firm started it.

Jun 3, 2024Firm started the recall
Jul 12, 2024FDA classified it Class II
Jul 24, 2024Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/54934-qiagen-qiacube-connect-mdx-recall-heater-shaker-module-may-cause">Qiagen QIAcube Connect MDx Recall: Heater Shaker Module May Cause Delayed Results (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-2353-2024 (June 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2353-2024 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.