Nova Biomedical Corporation is recalling 4,327 StatStrip Hospital Meter Systems because a software bug in the firmware can cause the devices to transmit incorrect patient test results to a hospital's records system. This error occurs when a user navigates to the "Review Results" screen while the meter is wirelessly transmitting data to the institution's management system. The recall includes model numbers 63685, 63683, and 63910 with software versions v0.0.13.10 through v0.0.13.44, which were distributed to hospitals and healthcare institutions.
The software bug can cause erroneously high or low glucose or ketone results to be documented in a patient's medical record. If medical staff rely on these incorrect results, it may lead to dangerous and incorrect treatment decisions, such as administering improper doses of medication. No injuries have been reported to date.
Prescription use blood glucose meter for near-patient testing; 2,365 units affected.
Prescription use blood glucose ketone meter for near-patient testing; 347 units affected.
Prescription use blood glucose ketone meter for near-patient testing; 1,615 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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