Redwood City, CA, United States
Biointellisense Inc. recalls
1 recall recorded since 2018, most recently on 19 July 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 July 2024
- Reason
- Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
- Distribution
- U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2616-2024
- 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 pati
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.