Biointellisense Inc.: 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

Hazard

Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

Details from the source

Reason for recall: 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 Quantity: 135,414 devices (U.S. 95,414 and O.U.S. 40,000) Lot/code info: Part Number: BIOST06040 UDI-DI code: 00850005949299 UDI code/Lot Number /BioID: U.S. 01008500059492991095422964 95422964 1897-529-643 01008500059492991095422964 95422964 2273-984-549 01008500059492991095422964 95422964 2353-391-610 01008500059492991095422964 95422964 1983-418-284 01008500059492991095422964 95422964 2197-213-247 01008500059492991095422964 95422964 2195-552-499 01008500059492991095422964 95422964 0776-970-222 01008500059492991095422964 95422964 0759-262-015 01008500059492991095422964 95422964 0693-068-049 01008500059492991095422964 95422964 1037-592-544 01008500059492991095422964 95422964 0586-886-801 01008500059492991095422964 95422964 0725-951-385 01008500059492991095422964 95422964 2837-953-215 01008500059492991095422964 95422964 1908-223-951 01008500059492991095422964 95422964 1564-661-854 01008500059492991095422964 95422964 1371-357-677 01008500059492991095422964 95422964 1491-596-810 01008500059492991095422964 95422964 1300-630-104 01008500059492991095422964 95422964 1497-784-550 01008500059492991095422964 95422964 1304-916-970 01008500059492991095422964 95422964 1690-284-987 01008500059492991095422964 95422964 1387-183-307 01008500059492991095422964 95422964 1691-252-142 01008500059492991095422964 95422964 2837-106-528 01008500059492991095422964 95422964 2841-866-964 01008500059492991095422964 95422964 2467-553-052 01008500059492991095422964 95422964 2436-514-105 01008500059492991095422964 95422964 1716-554-425 01008500059492991095422964 95422964 1749-71

UPC codes

00850005949299

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.