Qiagen Sciences LLC is recalling 419 units of the QIAcube Connect MDx IVD instrument, an automated tool used for isolating and purifying nucleic acids in medical diagnostics. The device's heater shaker module may fail to heat if the temperature is set below 40°C during certain DNA isolation protocols, specifically when using the QIAamp DSP DNA Mini Kit. This defect can lead to delayed or incorrect test results depending on the specific laboratory test being performed. The recall affects units with serial numbers between 30000 and 30506.
The heater shaker module does not activate heating for static incubation steps set below 40°C, which can compromise the enzymatic lysis process required to isolate DNA from Gram-positive bacteria. This failure to maintain the correct temperature may result in insufficient DNA yields, leading to erroneous diagnostic results or delays in patient care.
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Sources: FDA iRES · Raw API Response
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