The Recall Desk
Severity pendingFDA (Devices)·Z-0802-2026·Announced 2025-12-10

Allergy & Food Intolerance Test

Pending LLM rewrite. Source: FDA_DEVICE Z-0802-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Distribution without premarket approval/clearance.

The recalled product

Product
Allergy & Food Intolerance Test
Manufacturer
GET TESTED INTERNATIONAL AB

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • EAN: 616612785497
  • SKU: 1B2
  • UDI-DI: None
  • Lot/Serial Number: All Lots

Distribution

Distributed nationwide across the United States.