Qiagen Sciences LLC is recalling 168 units of the EZ2 Connect MDx-IVD, an automated instrument used for isolation and purification of nucleic acids in diagnostic laboratories. A defect in the welding of the heater cable can cause the cable to become brittle and fail, preventing the instrument from reaching the necessary temperature. If this occurs, the instrument may stop during operation, which will result in the loss of the biological sample being processed. This recall affects 38 units in the United States and 130 units internationally.
The heater cable failure can cause the instrument to display 'ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE' and stop mid-run. This leads to the immediate loss of potentially critical diagnostic samples and could delay medical results or require re-sampling from patients.
Instrument maintenance or technical correction
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Sources: FDA iRES · Raw API Response
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