HIGH

GET TESTED INTERNATIONAL AB Recalls Intestinal Worms Test

GET TESTED INTERNATIONAL AB recalled 45 units of its Intestinal Worms Test on November 3, 2025. The recall stems from distribution without necessary premarket approval or clearance. Healthcare providers and patients must stop using the product immediately.

Quick Facts at a Glance

Recall Date
November 3, 2025
Hazard Level
HIGH
Brand
GET TESTED INTERNATIONAL AB
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Distribution without premarket approval/clearance.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall affects the Intestinal Worms Test, with model numbers EAN: 616612785978 and SKU: 2A169. The product was distributed nationwide in the United States. No price information was provided.

The Hazard

The device was distributed without premarket approval or clearance. This lack of regulation raises significant safety concerns regarding its efficacy and potential risks.

Reported Incidents

No injuries or incidents related to the use of this device have been reported. However, the high hazard level indicates serious regulatory compliance issues.

What to Do

Patients and healthcare providers must stop using the Intestinal Worms Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.

Contact Information

For more information, contact GET TESTED INTERNATIONAL AB. Visit the FDA's website at the following link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0785-2026.

Key Facts

  • Recall Date: November 3, 2025
  • Report Date: December 10, 2025
  • Quantity Recalled: 45 units
  • Distribution: US Nationwide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
EAN: 616612785978
SKU: 2A169
UDI-DI: None
Lot/Serial Number: All Lots
Affected States
ALL
Report Date
December 10, 2025
Recall Status
ACTIVE

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