Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 18, 2020
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
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 coul…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Qiagen Sciences LLC recalled QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid t… - a moderate-severity action.
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid t… was recalled by Qiagen Sciences LLC in March 18, 2020. Reason: When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the …. Check the official notice for the remedy. Verify recall #Z-1476-2020 with the FDA Devices before acting.
The recall
Qiagen Sciences LLC issued this moderate-severity FDA Devices recall-When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the ….
- Moderate
- severity level
- Class II
- classification
- March 18, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1476-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1476-2020) was formally reported on March 18, 2020, with the manufacturer initiating the action on January 28, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Qiagen Sciences LLC is listed as the recalling firm, operating out of Germantown, MD. Federal records list the affected scope as 11418 instruments.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bosnia, Brazil, Brunei Darussala…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11418 instruments
Related Recalls
6
3 from same agency
Product description
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Reason for 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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1476-2020 |
| Date reported | March 18, 2020 |
| Date initiated | January 28, 2020 |
| Recalling firm | Qiagen Sciences LLC |
| Firm location | Germantown, MD |
| Affected scope | 11418 instruments |
| 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, Cambodi… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1476-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Qiagen Sciences LLC. Units affected: 11418 instruments.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2020. Severity: Moderate. Recall number: Z-1476-2020.
Where was the recalled product distributed? ▼
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, 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1476-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 18, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.