Biointellisense BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System recall — FDA Z-2616-2024
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Overview of recall records associated with Biointellisense Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
This page summarizes recall records in which the official source identifies Biointellisense Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.