ImmunoPass recall
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Why was ImmunoPass recalled?
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all lots
- Product
- ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
- Recalling firm
- Empowered Diagnostics LLC
- Quantity
- 2100 units
- Distribution
- US Nationwide Distribution
- Recall date
- February 9, 2022
- Classification
- Class I
- Status
- Completed
- Agency
- FDA (device)