QIAGEN Rotor Gene Q Software version 2.3.4
Medical device recall Z-1476-2020. Published in FDA’s Enforcement Report on Mar 18, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 18, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 11418 instruments how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
11418 instruments, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software version 2.3.4 used in the following: Product No. / Description 9001680 Rotor-Gene Q 2Plex no PC 9001680R Rotor-Gene Q 2Plex no PC refurbished 9001690 Rotor-Gene Q 2Plex HRM no PC 9001690R Rotor-Gene Q 2Plex HRM no PC refurbished…
Every code shown here, 2,000 characters
Software version 2.3.4 used in the following: Product No. / Description 9001680 Rotor-Gene Q 2Plex no PC 9001680R Rotor-Gene Q 2Plex no PC refurbished 9001690 Rotor-Gene Q 2Plex HRM no PC 9001690R Rotor-Gene Q 2Plex HRM no PC refurbished 9001700 Rotor-Gene Q 5Plex no PC 9001700R Rotor-Gene Q 5Plex no PC refurbished 9001710 Rotor-Gene Q 5Plex HRM no PC 9001710R Rotor-Gene Q 5Plex HRM no PC refurbished 9001720 Rotor-Gene Q 6Plex no PC 9001720R Rotor-Gene Q 6Plex no PC refurbished 9001960 Rotor-Gene AusDx (Outback Red) 9002000 Rotor-Gene Q MDx 2Plex 9002001 Rotor-Gene Q MDx 2Plex no PC 9002010 Rotor-Gene Q MDx 2Plex HRM 9002011 #Rotor-Gene Q MDx 2Plex HRM no PC 9002020 Rotor-Gene Q MDx 5Plex 9002021 Rotor-Gene Q MDx 5Plex no PC 9002029 Rotor-Gene Q MDx 5plex, PrioPLUS 9002030 Rotor-Gene Q MDx 5Plex HRM 9002030R Rotor-Gene Q MDx 5Plex HRM refurbished 9002031 Rotor-Gene Q MDx 5Plex HRM no PC 9002040 Rotor-Gene Q MDx 6Plex 9002041 Rotor-Gene Q MDx 6Plex no PC90275010 9002204 Rotor-Gene Q DBV 9023241 Rotor-Gene Q Software 9002370 5 plex MDx HRM with laptop (canada) This issue can affect the following QIAGEN IVD kits: Catalogue number Product Name 4514363 artus BK Virus QS-RGQ Kit (24) 4514263 artus BK Virus RG PCR Kit (24) 4514265 artus BK Virus RG PCR Kit (96) 4503363 artus CMV QS-RGQ Kit (24) 4503263 artus CMV RG PCR Kit (24) 4503265 artus CMV RG PCR Kit (96) 4501363 artus EBV QS-RGQ Kit (24) 4501263 artus EBV RG PCR Kit (24) 4501265 artus EBV RG PCR Kit (96) 4506366 artus HBV QS-RGQ (72) 4506356 artus HBV QS-RGQ Kit (24) 4506363 artus HBV QS-RGQ Kit (24) 4506263 artus HBV RG PCR Kit (24) 4506265 artus HBV RG PCR Kit (96) 4518356 artus HCV QS-RGQ Kit (24) 4518363 artus HCV QS-RGQ Kit (24) 4518366 artus HCV QS-RGQ Kit (72) 4538366 artus HCV QS-RGQ Kit V2 4518253 artus HCV RG RT-PCR Kit (24) 4518263 artus HCV RG RT-PCR Kit (24) 4518265 artus HCV RG RT-PCR Kit (96) 4513363 artus HI Virus-1 QS-RGQ Kit (24) 4513366 artus HI Virus-1 QS-RGQ Kit (72) 4513253 artus HI Virus-1 RG…
FDA’s list runs to 2,407 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macao, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mayotte, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory Occupied, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab, Republic of Taiwan, Tajikistan, Thailand, Timor-Leste (else known as East Timor), Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic of, Viet Nam, Yemen.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 28, 2020.
- FDA classified it on Mar 12, 2020.
- FDA’s Enforcement Report published it on Mar 18, 2020.
- FDA terminated it on Sep 26, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Qiagen Sciences LLC, of Germantown, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,407 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.