FDA Device recall Z-0324-2023
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200
- FDA Device
- Class II
- ongoing
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200 by Gs Biomark, citing distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0324-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-08 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Gs Biomark |
| Distribution | CA, DC, GA, IN, MD, NJ, NY, OR, PA, TX, WA |
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
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Identifiers
| code_info | CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers / Lot Numbers: BC-DK0200 / 42821005 BM-AD4K0200 / 1104210…CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers / Lot Numbers: BC-DK0200 / 42821005 BM-AD4K0200 / 110421005, 110121005, 62322004 BM-ADK0200 / 110121003 BM-CDK0200 / 110121004 BM-CFDK0200 / 110121006 BM-D4K0200 / 71221003, 72021004, 81021003, 92721002, 102521003, 112221002, 30122001 BM-DK0200 / 51821001, 71221002, 72021003, 72721001, 80521001, 80921003, 81021002, 90721003, 90721004, 90921003, 90921003, 90921003, 102521002, 111521002, 22422002 BM-DK0600 / 110521002, 10722003, 12122004 BM-DK0800 / 12722006 BM-DK1200 / 120221002, 50222002 BM-DK1400 / 92421002, 101821005, 32222004 BM-DK1800 / 92321001, 92421001, 101821004, 110521001, 112321001, 120221001, 10722002, 12122002, 12722005, 32222003, 50222001, 60622001, 62922001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0324-2023%22
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