DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

Recall Insight

This FDA Devices action (record #Z-3307-2024) was formally reported on October 9, 2024, with the manufacturer initiating the action on June 26, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD is listed as the recalling firm, operating out of Shenzhen, N/A. Federal records indicate 120,000 kits units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States. Distribution data in the federal record shows the product reached: International distribution to the countries of China and Hong Kong.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.