Summary
The FDA issued a Class I for ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 by Empowered Diagnostics LLC. Reason: COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from F.
Details
Source
Device Recall
External ID
Z-0481-2022
Action Date
2022-02-09
Status
Completed
Category
device
Product Description
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Lot/Code Info: all lots
Quantity Affected: 2100 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-22
Company
Pompano Beach, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 95 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Empowered Diagnostics LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Empowered Diagnostics LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Empowered Diagnostics LLC have FDA actions?
Empowered Diagnostics LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0481-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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