Z-0324-2023Class II

CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200...

Name: Z-0324-2023 CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200...
Creator: GS Biomark LLC
Published: 2022-08-08
License: https://open.fda.gov/license/

GS Biomark LLC / initiated 2022-08-08 / Open, Classified

FDA source

GS Biomark LLC began a recall of 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... on 2022-08-08. FDA classified it as Class II and gives the reason as "Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0324-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-08
Posted: 2022-11-29
Recalling firm: GS Biomark LLC
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
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
FDA root cause: No Marketing Application
Action: On 08/08/2022, GS Biomark emailed customer to notify them that their COVID test kits - CoViPoint COVID test kit (MultiPLEX/Direct) have expired and to destroy unused material that they still have on-hand. Customer were not informed that the affected products did not have Emergency Use Authorization to distributed the product within the U.S.
Quantity in commerce: 639,200 kits
Distribution: U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0324-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0324-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-29

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)