China NMPA Product Recall - MiSeq™ Dx Instrument for gene sequencing

On August 5, 2020, Inmina (China) Scientific Instruments Co., Ltd. initiated a voluntary Class III recall of its MiSeq™ Dx Instrument gene sequencers. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses a specific product issue identified by the company.

The primary issue stems from a deviation in some MiSeqDx instruments where an increased current was detected in the M3 motor driver. This elevated current carries a risk of motor failure within the gene sequencers. While investigations confirmed that these motor failures would not lead to incorrect patient test results, they are expected to cause operational stoppages, resulting in potential delays in delivering test outcomes to customers.

As a required action, Inmina (China) Scientific Instruments Co., Ltd. is voluntarily recalling the affected MiSeq™ Dx Instrument gene sequencers. The Class III classification indicates that while the issue is not anticipated to cause serious adverse health consequences, corrective measures are necessary to prevent operational disruptions and ensure product reliability. Specific details regarding affected models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form.