Reported Feb 9, 2022 · Completed
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Empowered Diagnostics LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Empowered Diagnostics LLC · 3341 W Mcnab Rd · Pompano Beach, FL · 33069-4808
Is this the product you have?
ImmunoPassCOVID-19 Neutralizing Antibody TestNAB 900-60
- Lot codes and dates
- all lots
- Amount recalled
- 2100 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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