One Step K in vitro diagnostic test REF: 81A4 - The devices were distributed without required FDA premarket clearance or approval.

Source: FDA | Recall date: 05/13/2026

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Affected product: One Step K in vitro diagnostic test REF: 81A4

Summary: The devices were distributed without required FDA premarket clearance or approval.

Hazard: The devices were distributed without required FDA premarket clearance or approval.

Track your baby products and get automatic recall alerts when something may affect your family.