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Recall Observatory FDA recall evidence

Device product

Hair Mineral Analysis

Z-0783-2026

November 03, 2025

Class II

Product summary

Firm
GET TESTED INTERNATIONAL AB
Event
Event 97896
Status
Ongoing
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-0783-2026

Official wording

Reason: Distribution without premarket approval/clearance.

Code information: EAN: 616612786074; SKU: E190; UDI-DI: None; Lot/Serial Number: All Lots;

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Distribution without premarket approval/clearance.

Field note

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