CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

Recall Insight

This FDA Devices action (record #Z-0324-2023) was formally reported on December 7, 2022, with the manufacturer initiating the action on August 8, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. GS Biomark LLC is listed as the recalling firm, operating out of Bellevue, WA. Federal records indicate 639,200 kits units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization. Distribution data in the federal record shows the product reached: U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None. 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 4 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.