Qiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results
A heating defect in the Qiagen QIAcube Connect MDx may prevent proper incubation temperatures below 40°C, potentially affecting diagnostic test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall for a functional defect in a diagnostic instrument that could cause inaccurate test results. While no illnesses or injuries have been reported, the risk of erroneous diagnostic results qualifies as a risk-of-harm product where injury has not yet been reported per the FDA severity rubric.
Plain-English summary
Qiagen Sciences LLC has recalled the QIAcube Connect MDx (Model 900370, Software Version 1.0.1), an automated instrument used to isolate and purify nucleic acids in molecular diagnostics and research. The device contains a heater shaker module with a functional defect.
The heater does not perform heating when temperature is set below 40°C during static incubation steps in protocols such as the QIAamp DSP DNA Mini Kit protocol for isolating genomic DNA from Gram-positive bacteria. This malfunction could lead to delayed or erroneous results in downstream assays, potentially affecting diagnostic accuracy.
The recall affects 419 units with serial numbers 30000-30506. The product was distributed nationwide and to multiple foreign countries including Canada, China, India, and others. Affected serial numbers shipped to date are in the range of 30000-30506.
Customers using the affected devices, particularly those performing bacterial genomic DNA isolation and related protocols, should contact Qiagen Sciences LLC for instructions. The manufacturer is providing supplemental operating instructions for heater operation at temperatures of 40°C or lower with future unit shipments.
The recalled product
- Product
- QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
- Manufacturer
- Qiagen Sciences LLC
- Hazard
- heating-malfunction
- erroneous-results
Distribution
Distributed nationwide across the United States.
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