Biointellisense Inc. recalls BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous…
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Read the official notice →- Date
- 2024-08-21
- Country
- United States
- Brand
- Biointellisense Inc.
- Product
- BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous…
- Classification
- Class II
- Units
- U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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