The Food and Drug Administration (FDA) has issued a Class II recall for the Wondfo Streptococcal A At-Home Self-Test. The reason for the recall is that the product has not received FDA clearance, indicating a potential risk to public health. The recall impacts nationwide distribution within the United States.

Companies involved in the distribution or sale of this test must immediately cease distribution and comply with FDA recall procedures. While specific penalties are not detailed, failure to comply with recall directives can result in enforcement actions. Healthcare providers and consumers should be aware of this recall and discontinue use of the affected product.