Empowered Diagnostics LLC ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Brand
Empowered Diagnostics LLC
Lot Codes / Batch Numbers
all lots
Products Sold
all lots
Empowered Diagnostics LLC is recalling ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 due to COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from F. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Recommended Action
Per FDA guidance
The firm notified their direct consignees by letter delivered by email on December 22, 2021. The letter explained the hazard and requested the discontinuation of use and distribution. Those who has further distributed the products, were requested to conduct a sub-recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026