FDAFDA · Food and drugs·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 patient is at rest.
Published August 21, 2024 · Recall initiated: July 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biointellisense Inc.
- Distributor
- U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
- Lot
- 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 1749-713-834 01008500059492991095422964 95422964 1750-319-768 01008500059492991095422964 95422964 3218-162-830 01008500059492991095422964 95422964 3375-451-062 01008500059492991095422964 95422964 3458-102-837 01008500059492991095422964 95422964 3451-172-426 01008500059492991095422964 95422964 3459-644-173 01008500059492991095422964 95422964 3535-383-398 01008500059492991095422964 95422964 0065-120-297 01008500059492991095422964 95422964 2663-792-243 01008500059492991095422964 95422964 2851-670-555 01008500059492991095422964 95422964 2847-583-072 01008500059492991095422964 95422964 1667-709-162 01008500059492991095422964 95422964 1845-931-994 01008500059492991095422964 95422964 1759-287-032 01008500059492991095422964 95422964 1487-876-615 01008500059492991095422964 95422964 1734-315-465 01008500059492991095422964 95422964 1879-141-839 01008500059492991095422964 95422964 2201-234-681 01008500059492991095422964 95422964 0861-639-348 01008500059492991095422964 95422964 0877-638-597 01008500059492991095422964 95422964 0890-588-752 01008500059492991095422964 95422964 0955-581-609 01008500059492991095422964 95422964 3483-974-934 01008500059492991095422964 95422964 2937-219-412 01008500059492991095422964 95422964 1788-505-848 01008500059492991095422964 95422964 1843-421-327 01008500059492991095422964 95422964 3464-772-013 01008500059492991095422964 95422964 3592-734-405 01008500059492991095422964 95422964 2684-505-797 01008500059492991095422964 95422964 2729-638-787 01008500059492991095422964 95422964 2431-532-861 01008500059492991095422964 95422964 2471-192-432 01008500059492991095422964 95422964 2424-735-455 01008500059492991095422964 95422964 0697-847-896 01008500059492991095422964 95422964 0303-324-614 01008500059492991095422964 95422964 0203-411-884 01008500059492991095422964 95422964 0412-193-772 01008500059492991095422964 95422964 0334-856-178 01008500059492991095422964 95422964 4011-634-650 01008500059492991095422964 95422964 2144-385-480 01008500059492991095422964 95422964 2124-652-734 01008500059492991095422964 95422964 1432-299-134 01008500059492991095422964 95422964 2653-217-727 01008500059492991095422964 95422964 2504-850-442 01008500059492991095422964 95422964 2332-387-628 01008500059492991095422964 95422964 2353-395-415 01008500059492991095422964 95422964 0050-138-321 01008500059492991095422964 95422964 1975-273-289 01008500059492991095422964 95422964 1954-220-447 01008500059492991095422964 95422964 1924-664-064 01008500059492991095422964 95422964 1881-517
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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