Qiagen Rotor-Gene Q Software Recall for Incorrect Concentration Reporting
Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the defect could lead to serious medical consequences such as the suspension or non-initiation of treatment, which aligns with the rubric criteria for Severe severity involving significant injury or risk of harm.
Plain-English summary
Qiagen Sciences LLC is recalling 11,418 Rotor-Gene Q real-time PCR analyzers equipped with software version 2.3.4. The recall covers various instrument configurations, including 2Plex, 5Plex, 6Plex, and MDx models, as well as specific IVD kits used with the system. The affected instruments were distributed worldwide, including nationwide in the United States and in numerous other countries.
The recall is due to a software defect that occurs when completing a Laboratory Information Management System (LIMs) export. In these instances, the generated .csv file reports the calculated concentration result value as a logarithmic value rather than the correct linear value. This error could lead to false negative results in PCR assays.
False negative results from these diagnostic tests could have serious medical consequences for patients, including the suspension or non-initiation of necessary medical treatment. Users of the affected software version should contact Qiagen Sciences LLC for instructions on how to resolve the issue.
The recalled product
- 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.
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 11,418
Distribution
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