FDA recall Z-1461-2022

Product

etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

Reason for recall

Device was marketed without FDA 510(k) clearance or a PMA.

Distribution

US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA

Key facts

Status

Ongoing

Initiation date

2022-06-21

Report date

2022-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Paramus, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2022