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Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
Nova Biomedical is correcting StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect glucose patient test results to be transmitted to hospital medical record systems. The issue occurs when an operator visits the “Review Results” screen to review previous historical test results while the meter is still in the process of transmitting current results wirelessly to the system.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Nova Biomedical Corporation Technical Support at 1-800-545-6682.
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