Recall Z-0481-2022— Empowered Diagnostics LLC

Name: FDA recall Z-0481-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Class I · Completed

Class I FDA medical device recall by Empowered Diagnostics LLC, initiated 2021-12-22. FDA's recall record names no specific 510(k) clearance for this event. Product: ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60. Reason: COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA..

Recalling firm: Empowered Diagnostics LLC
Classification: Class I
Status: Completed
Initiated: 2021-12-22
Firm location: Pompano Beach, FL, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.