FDA on October 20 flagged Nova Biomedical's removal of its Gen 2.0 StatStrip Glucose Hospital Meter System as the most serious type of recall. When an operator scans a patient ID or quality control barcode, data from a previous scan can stay on screen. Accept it, and the glucose result files under the wrong patient.
The affected products are model 63685 and the model 66739 multipack, on all firmware versions. The earlier Gen 1.86 meter is not included. Nova sent its first customer letter on July 31 and updated it on October 5. As of that date it had reported one serious injury and no deaths.
Nova has put a shipment hold on new Gen 2.0 meters and plans a phased software update starting in November 2026. Until then it tells sites to move to an alternative meter where one exists. It also tells them to enable Validate Patient ID's in NovaNet where ADT data is available, set operator logoff to Test mode, and check the ID on screen after every scan.
Measurement accuracy is not in question here, which is what makes the failure hard to catch. The number on the screen is correct for somebody. Critically ill patients and infants carry the most risk, since neither can report hypoglycemia.