Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1476-2020 — QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

U.S. FDA — Device Enforcement · United States · 2020-01-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1476-2020
Date of alert: 2020-01-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Qiagen Sciences LLC
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1476-2020 — QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

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