FDA WARNING_LETTER - Cantronic Systems Inc. - February 11, 2021

On February 11, 2021, the FDA reviewed Cantronics' website, https://www.cantronics.com, and found that the company offers several "Temperature Scanners" (FeverScan M3000N, M3000L, LGC300, M3000B, M3000SD, M3000S, M3000P02, M3000P03, M3000P04, and M3000P05) for sale in the United States. The FDA determined these products are medical devices intended for diagnosing or preventing disease, or affecting body function, specifically for human body temperature measurement.

The FDA cited two primary violations: 1. **Adulteration:** The Temperature Scanners are adulterated under section 501(f)(1)(B) of the Act because they are offered for sale without required marketing approval, clearance, or authorization (PMA or IDE) from the FDA. 2. **Misbranding:** The products are misbranded under section 502(o) of the Act because Cantronics failed to notify the FDA of its intent to introduce these products into interstate commerce for commercial distribution, as required by section 510(k).

The FDA highlighted public health risks associated with these devices, including incorrect temperature detection, especially when scanning