FDA flags StatStrip Gen 2 hospital meters over patient-ID mix-up risk
FDA says affected Nova hospital meters can associate a glucose result with the wrong patient record; older Gen 1.86 models are excluded.
What the record says
FDA's October 20 notice identifies StatStrip Glucose Hospital Meter System Gen 2.0 models 63685 and multipack 66739. Nova reports that prior patient or quality-control information may remain after a barcode scan and, if accepted, assign a result to the wrong record. FDA says the issue does not affect the analytical performance of the glucose measurement itself. The agency lists one serious injury and no deaths reported as of October 5.
Source details and supporting locations.
Practical next step
Healthcare facilities should consult the FDA notice and Nova's customer advisory for affected devices, removal and mitigation instructions, and patient-record checks while awaiting a software update.
Limits and what is not established
This concerns identified hospital-use Gen 2.0 systems, not all glucose meters or older Gen 1.86 models. A planned November software rollout is not proof that an update is available now. Patients should not change treatment based on this report.
Sources checked October 21, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information