FDA recall Z-0324-2023

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.

Distribution

U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: None

Key facts

Status

Ongoing

Initiation date

2022-08-08

Report date

2022-12-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bellevue, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2023