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Hospital Glucose Meter Correction: Nova Biomedical Updates Use Instructions for StatStrip Glucose Hospital Meter Systems
FDA has updated the communication “Hospital Glucose Meter Removal: Nova Biomedical Removes StatStrip Glucose Hospital Meter Systems” to clarify the recommended actions for customers affected by this issue.
The FDA is aware that Nova Biomedical has issued a letter to affected customers recommending updated instructions for use for certain StatStrip Glucose Hospital Meters. The updated instructions should be followed until a software update is available. If an alternative device is available, customers should stop using the affected StatStrip Glucose Hospital Meter until the software update becomes available.
This issue only applies to the most recent model of the StatStrip Glucose Hospital Meter System, the “Gen 2.0”, and does NOT apply to any previously released model of the StatStrip Glucose Hospital Meter System.
Questions?
Customers in the U.S. with questions about this recall should contact Nova Biomedical at 1(800) 545-6682.
This recall involves implementing additional recommendations on the use of the StatStrip Glucose Hospital Meter System while awaiting a software update. If customers have an alternative meter, they should stop using the affected StatStrip meter until it is updated if the defect occurs. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
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