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Biointellisense Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Biointellisense Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-08-21FDA-DeviceClass IIBioButton 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.
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
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