Lower risk Medical device recall · FDA · Published January 28, 2020

Qiagen Rotor Gene Q Software 2.3.4: False Negative Risk in PCR Tests

Qiagen recalls software version 2.3.4 for Rotor Gene Q PCR analyzers that may report false negative results in certain tests, risking treatment suspension or non-initiation of medical treatment.

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

🇺🇸 FDA recall #Z-1476-2020Medical device Qiagen ›

Lower-risk recall

When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Qiagen is recalling software version 2.3.4 for their Rotor Gene Q PCR analyzers. This version can cause false negative results in specific tests, which might lead to serious medical consequences like treatment suspension or failure to start treatment. Read more at govinfonow.com/recall/65947-qiagen-rotor-gene-q-software-2-3-4-false-negative.

Source Summary by GovInfoNow · govinfonow.com/recall/65947-qiagen-rotor-gene-q-software-2-3-4-false-negative · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1476-2020

Cite this page

“Qiagen Rotor Gene Q Software 2.3.4: False Negative Risk in PCR Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65947-qiagen-rotor-gene-q-software-2-3-4-false-negative. Based on FDA recall #Z-1476-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2020%22&limit=1).

The FDA announced on Jan. 28, 2020, that Qiagen Sciences LLC is recalling QIAGEN Rotor Gene Q Software version 2.3.4 because it may report calculated concentration results as logarithmic values, potentially leading to false negative results and serious medical consequences.

How to tell if you have it

Brand: Qiagen
Product: QIAGEN Rotor Gene Q Software version 2.3.4
Affected Product Nos.: 9001680, 9001680R, 9001690, 9001690R, 9001700, 9001700R, 9001710, 9001710R, 9001720, 9001720R, 9001960, 9002000, 9002001, 9002010, 9002011, 9002020, 9002021, 9002029, 9002030, 9002030R, 9002031, 9002040, 9002041, 90275010, 9002204, 9023241, 9002370
Units affected: 11,418 instruments

The hazard

When using the Rotor-Gene Q with Software version 2.3.4 to complete a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value. This error could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment.

Context

GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Recent similar recalls include the Qiagen QIAstat-Dx Respiratory Panel Plus recall on March 12, 2025, and the Qiagen QIAcube Connect MDx Recall on June 3, 2024. Other recent recalls of similar products include the BioFire Respiratory Panel 2.1 recall (June 24, 2026), the LH One Step Ovulation Test Device Recall (Nov. 22, 2025), and the Menopause Test Cassette Recall (Nov. 22, 2025).

How to tell if you have this one

Check if your Rotor Gene Q software is version 2.3.4. Affected products include specific model numbers like 9001680, 9001690, 9001700, and associated IVD kits with catalog numbers starting with 4500000.

Brand
Qiagen
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Update Software
Download and install the latest software version from Qiagen's official website to fix the false reporting issue.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Cambodia,…” 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 terminated this recall 4.7 years after the firm started it.

Jan 28, 2020Firm started the recall
Mar 12, 2020FDA classified it Class II
Mar 18, 2020Published in FDA’s Enforcement Report
Sep 26, 2024FDA terminated the recall

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/65947-qiagen-rotor-gene-q-software-2-3-4-false-negative">Qiagen Rotor Gene Q Software 2.3.4: False Negative Risk in PCR Tests (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-1476-2020 (January 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1476-2020 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.