FDA clarifies safety steps for StatStrip Gen 2.0 glucose meters

Published November 4, 2026 · Coverage October 25–31, 2026, Pacific · High priority

FDA says prior patient or quality-control information can remain on the affected meter screen and, if accepted, assign a glucose result to the wrong record. The agency says users with an alternative meter should stop using the affected meter until it is updated. Where no alternative is available, users should follow the manufacturer’s interim safeguards, including the identification checks described in the FDA communication. FDA reported one serious injury and no deaths as of October 5.

Patient identification and glucose testing

Illustrative artwork; not evidence of the actual people, products or events described.

Suggested owner and action: Clinical operations, laboratory, biomedical engineering and patient-safety teams can identify affected models, review the FDA’s current instructions and confirm their organization’s mitigation and software-update plan. The recommendation depends on whether an alternative device is available.

FDA correction and communication timeline

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