COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale
Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, the most serious regulatory classification. Although no illnesses, injuries, or deaths have been reported, Class I recalls warrant a minimum severity of 4 (Severe). The regulatory violation of marketing an unapproved diagnostic device without FDA authorization justifies the Severe rating.
Plain-English summary
Empowered Diagnostics LLC is recalling the ImmunoPass COVID-19 Neutralizing Antibody Test (NAB 900-60) across all production lots. Approximately 2,100 units of this test kit were distributed nationwide to consumers.
The test kits were offered for sale and distributed to the public without FDA marketing approval, clearance, or authorization. FDA has classified this as a Class I recall, reflecting the serious regulatory violation of distributing an unapproved medical device. Consumers cannot independently verify whether these tests provide accurate or reliable results.
Consumers who obtained these test kits should not use them. The reliability and accuracy of the test results cannot be assured because the product was not reviewed or cleared by the FDA prior to distribution. Anyone with questions should contact Empowered Diagnostics LLC or consult a healthcare provider.
The recalled product
- Product
- ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
- Manufacturer
- Empowered Diagnostics LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 2,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Empowered Diagnostics LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Empowered Diagnostics LLC
See all →- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
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