Touch US Llc recalls etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
- Recall date
- June 21, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1461-2022
- FDA classification
- Class II
- Brand / firm
- Touch US Llc
- Sold / distributed
- US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Why it was recalled
Device was marketed without FDA 510(k) clearance or a PMA.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
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