BioButton Remote Monitoring Device Software Accuracy Issue
A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves inaccurate temperature measurement on a remote monitoring device. The measurement inaccuracy presents a risk of harm in clinical decision-making and patient safety, matching the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The BioButton REF BIOST06040 with Software version 3.0.20 is a remote monitoring wearable device designed for continuous collection of physiological data in home and healthcare settings. A software anomaly causes the device's skin temperature measurements to be slightly out of specification.
The recall involves 135,414 devices: 95,414 distributed in the United States (California, Colorado, Massachusetts, Tennessee, and Texas) and 40,000 units outside the U.S. Multiple lot numbers are associated with the affected devices. No illnesses or injuries have been reported.
Users of affected devices should contact the manufacturer, Biointellisense Inc., for instructions on how to address this software issue. Healthcare providers should be aware that affected devices may provide temperature readings outside the manufacturer's specified accuracy parameters.
The recalled product
- Product
- BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
- Manufacturer
- Biointellisense Inc.
Distribution
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