Qiagen recalls software version 2.3.4 for Rotor Gene Q PCR analyzers that may report false negative results in certain tests, risking treatment suspension or non-initiation of medical treatment.
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
Qiagen is recalling software version 2.3.4 for their Rotor Gene Q PCR analyzers. This version can cause false negative results in specific tests, which might lead to serious medical consequences like treatment suspension or failure to start treatment.
When exporting LIMS data with software version 2.3.4, the .csv file incorrectly reports concentration results as logarithmic values. This can cause false negative results in critical tests, potentially leading to treatment suspension or failure to initiate necessary medical treatments.
Users of Qiagen Rotor Gene Q software version 2.3.4 for PCR testing, particularly those using the software with specific IVD kits like artus BK Virus, CMV, EBV, HBV, HCV, and other viral detection kits. Healthcare professionals and labs using these kits are most at risk.
Check if your Rotor Gene Q software is version 2.3.4. Affected products include specific model numbers like 9001680, 9001690, 9001700, and associated IVD kits with catalog numbers starting with 4500000.
Download and install the latest software version from Qiagen's official website to fix the false reporting issue.
Software version 2.3.4 reports concentration results as logarithmic values during LIMS exports, which can cause false negative results in critical tests, potentially leading to treatment suspension or failure to initiate necessary medical treatments.
The affected software version is 2.3.4 for Rotor Gene Q PCR analyzers. Specific model numbers include 9001680, 9001690, 9001700, and associated IVD kits with catalog numbers starting with 4500000.
Check your Rotor Gene Q software version. If it's 2.3.4, it's affected. Affected products include specific model numbers listed in the recall notice.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-1476-2020 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-1476-2020 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
