CoViPoint COVID test kit — Class II medical device recall Z-0324-2023
Ongoing recall by GS Biomark LLC, reported 2022-12-07, distributed in CA, DC, GA, IN, MD, NJ, NY, OR…. Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
| Recall number | Z-0324-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GS Biomark LLC, Bellevue, WA, United States |
| Recall initiated | 2022-08-08 |
| Classified | 2022-11-29 |
| Reported by FDA | 2022-12-07 |
| Distributed | CA, DC, GA, IN, MD, NJ, NY, OR, PA, TX, WA |
| Quantity | 639,200 kits |
| Lot numbers | 101821004, 101821005, 102521002, 102521003, 10722002, 10722003, 110121003, 110121004, 110121005, 110121006, 110421005, 110521001, 110521002, 111521002, 112221002, 112321001, 120221001, 120221002, 12122002, 12122004, 12722005, 12722006, 22422002, 30122001, 32222003, 32222004, 42821005, 50222001, 50222002, 51821001, 60622001, 62322004, 62922001, 71221002, 71221003, 72021003, 72021004, 72721001, 80521001, 80921003 and 21 more |
| Model numbers | BC-DK0200 |
Product
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
Reason for recall
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0324-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.