Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0

Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared.

The FDA classified the issue as a Class I recall, noting that the meter could assign glucose results to the wrong patient, which could lead to serious injury or death if not corrected. Users are told to stop using the device if an alternative meter is available until the update is applied.

The recall applies only to the Gen 2.0 model and not to earlier versions. Nova recommends reviewing the new instructions and following them until the software patch is released.