FDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
E25Bio COVID-19 diagnostic tests have been recalled following nationwide distribution without FDA authorization or approval. The distributed units lacked sufficient directions and quality controls needed for safe diagnostic use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Per the recall severity rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe). Although no illnesses or injuries have been reported, an unapproved COVID-19 diagnostic test was distributed nationwide without adequate directions or quality controls, presenting a potential diagnostic reliability risk.
Plain-English summary
E25Bio, Inc. has recalled its COVID-19 Direct Antigen Rapid Test (also marketed as the E25Bio COVID-19 DART Kit) following distribution without FDA authorization, clearance, or approval for clinical diagnostic or screening use.
The recalled test kits totaled approximately 73,300 units distributed nationwide between October 2020 and November 2021 to locations in Massachusetts, Florida, and Hawaii. Affected units can be identified by purchase order numbers 1006 through 1040, dated from October 13, 2020 through November 27, 2021.
The device was distributed without sufficient directions for use or adequate quality controls in place. The FDA has not verified that this test meets required safety and performance standards for clinical diagnostic use.
Consumers who have received E25Bio COVID-19 rapid tests should understand they are not FDA-authorized for diagnostic or screening purposes and lack adequate instructions and quality controls. Such tests should not be relied upon for clinical testing decisions.
The recalled product
- Product
- E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
- Manufacturer
- E25Bio, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unauthorized-device
- insufficient-directions
- inadequate-controls
Distribution
Distributed nationwide across the United States.
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