Z-0324-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- August 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 639,200 kits
Product Description
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.
Distribution Pattern
U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None
Code Information
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