Reported Aug 21, 2024 · Ongoing
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device…
Biointellisense Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biointellisense Inc. · 570 El Camino Real Ste 200 · Redwood City, CA · 94063-1248
Is this the product you have?
- 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.
- Lot codes and dates
- Part NumberBIOST06040
- UDI-DI code00850005949299
- UDI code/Lot Number /BioIDU.S.9
1,990 of 1,990 codes
01008500059492991095422964954229641897-529-64301008500059492991095422964954229642273-984-54901008500059492991095422964954229642353-391-61001008500059492991095422964954229641983-418-28401008500059492991095422964954229642197-213-24701008500059492991095422964954229642195-552-49901008500059492991095422964954229640776-970-22201008500059492991095422964954229640759-262-01501008500059492991095422964954229640693-068-04901008500059492991095422964954229641037-592-54401008500059492991095422964954229640586-886-80101008500059492991095422964954229640725-951-38501008500059492991095422964954229642837-953-21501008500059492991095422964954229641908-223-95101008500059492991095422964954229641564-661-85401008500059492991095422964954229641371-357-67701008500059492991095422964954229641491-596-81001008500059492991095422964954229641300-630-10401008500059492991095422964954229641497-784-55001008500059492991095422964954229641304-916-970
- Amount recalled
- 135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Where it was sold
Why it was recalled
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
This product could cause temporary or reversible health problems — stop using it.
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