United StatesThe DermaSensor device (Model/Catalog No. 10101, Software Version 3.0.2), a software‑aided adjunctive diagnostic device used by physicians on lesions suspicious for skin cancer, is being recalled; affected identifiers include UDI‑DI 085001778610101A9 and serial numbers 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, and 101012025093012EE03. The recall was issued because the device has the potential to not meet specifications, which could result in incorrect results or delay of referral for patients.
What's being recalled
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Recalling firm: Dermasensor Inc, Miami, FL, United States.
How to identify it
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
The hazard
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)