Class II — Biointellisense Inc.
| Recalling firm | BioIntelliSense Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |
| 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. |
| Quantity | 135,414 devices (U.S. 95,414 and O.U.S. 40,000) |
| Distribution | U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided |
| Initiated | 2024-07-19 |
| Classified | 2024-08-14 |
| Recall number | Z-2616-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biointellisense Inc. (Z-2616-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94943/
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