Reported Dec 7, 2022 · Ongoing
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200…
GS Biomark LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GS Biomark LLC · 1120 116th Ave NE, Suite 102 · Bellevue, WA · 98004
Is this the product you have?
- CoViPoint COVID test
- kit (MultiPLEX/Direct) Kit Item NumbersBC-DK0200;
BM-AD4K0200BM-ADK0200BM-CDK0200BM-CFDK0200BM-D4K0200BM-DK0200BM-DK0600BM-DK0800BM-DK1200BM-DK1400BM-DK1800
- Lot codes and dates
- CoViPoint COVID test kit (MultiPLEX/Direct)
- Kit Item Numbers / Lot NumbersBC-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
- Amount recalled
- 639,200 kits
Where it was sold
Why it was recalled
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
This product could cause temporary or reversible health problems — stop using it.
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