DFI Co., Ltd. — Class II: One Step K in vitro diagnostic test REF: 81A4
DFI Co., Ltd. initiated a Class II recall for the One Step K in vitro diagnostic test (REF: 81A4) because the devices were distributed without the required FDA premarket clearance or approval.
This affects DFI Co., Ltd., US-based distributors of their diagnostic products, and regulatory and quality assurance departments responsible for IVD market authorization.
The distribution of a Class II device without premarket notification (510(k)) or approval is a significant compliance failure that renders the product misbranded and adulterated under the FD&C Act. For international firms, this suggests a potential gap in the oversight of US-specific regulatory requirements during the distribution phase. Professional teams should note that 'Ongoing' status indicates that recovery or correction efforts are currently active.
Identify and quarantine any remaining stock of REF: 81A4; verify that all distributed IVD products have documented 510(k) clearance or PMA approval prior to market entry; audit international supply chain workflows to ensure US-specific regulatory requirements are met before importation.
Class II. Reason: The devices were distributed without required FDA premarket clearance or approval.. Product: One Step K in vitro diagnostic test REF: 81A4. Firm: DFI Co., Ltd. (Gimhae Korea (the Republic of)). Status: Ongoing.
Open in openFDA / FDA.gov