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U.S. Department of Health and Human Services

Class 1 Device Recall ImmunoPass , COVID19 Neutralizing Antibody Test

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 Class 1 Device Recall ImmunoPass , COVID19 Neutralizing Antibody Testsee related information
Date Initiated by FirmDecember 22, 2021
Create DateJanuary 29, 2022
Recall Status1 Completed
Recall NumberZ-0481-2022
Recall Event ID 89315
Product Classification Reagent, coronavirus serological - Product Code QKO
ProductImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Code Information all lots
Recalling Firm/
Manufacturer		 Empowered Diagnostics LLC
3341 W Mcnab Rd
Pompano Beach FL 33069-4808
Manufacturer 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.
FDA Determined
Cause 2		No Marketing Application
ActionThe 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.
Quantity in Commerce2100 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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