Class II — Qiagen Sciences LLC
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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. |
| Quantity | 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, Cambodia, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Ge… |
| Initiated | 2020-01-28 |
| Classified | 2020-03-12 |
| Terminated | 2024-09-26 |
| Recall number | Z-1476-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Qiagen Sciences LLC (Z-1476-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85004/
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