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Source: FDA | Recall date: 05/13/2026
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Affected product: One Step 10A in vitro diagnostic test
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.
Learn more about the baby product recall tracker, baby product recall alerts, or recall monitoring plans.