Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw

Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient.

The FDA classified the recall as the most serious type, warning that continued use of the device could cause serious injury or death. The recall does not affect earlier versions such as the Gen 1.86 model.

Customers were first notified on July 31 and received an updated letter on October 5. Nova advises users to remove the affected meters from use or sale until a software update is provided and to verify patient‑validation settings in their electronic medical record systems.