# FDA recall Z-1476-2020

> **Qiagen Sciences LLC** · Class II · device recall initiated 2020-01-28.

## Product

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

## 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 Arabi

## Key facts

- **Recall number:** Z-1476-2020
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-28
- **Report date:** 2020-03-18
- **Termination date:** 2024-09-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2020

## Citation

> AI Analytics. FDA recall Z-1476-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1476-2020. Source: US FDA. Licensed CC0.

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