Here are three notes:
- The company on Nov. 20 alerted customers to the issue, which was identified as a potential risk to patient safety, according to a Jan. 30 FDA news release. The agency has classified this recall as the most serious type.
- The issue arises when the meter’s “review results” screen is accessed while the device is transmitting current test results. This could lead to inaccurate historical test results being recorded in the hospital’s medical record system.
If left unaddressed, this could result in misdiagnoses such as incorrect treatment for hypoglycemia, hyperglycemia or ketoacidosis particularly in high-risk populations like neonates and intensive care patients.
3. No injuries or deaths have been reported. Healthcare providers have been instructed to distribute the correction notice and report any instances of incorrect data transmission to Nova Biomedical’s technical support team.
