QIAGEN Rotor Gene Q Software version 2 — Class II medical device recall Z-1476-2020
Terminated recall by Qiagen Sciences LLC, reported 2020-03-18, distributed nationwide. When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the ca
| Recall number | Z-1476-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2020-01-28 |
| Classified | 2020-03-12 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2024-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 11,418 instruments |
| Reason classes | software |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1476-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.