FDA recall Z-0481-2022

Product

ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

Reason for recall

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

Distribution

US Nationwide Distribution

Key facts

Status

Completed

Initiation date

2021-12-22

Report date

2022-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pompano Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2022