Ellume COVID-19 Home Test Recalled for Higher Rate of False Positives
Ellume recalled approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results. The affected kits were distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington.
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: The FDA classified this as a Class I medical device recall, which by definition requires a minimum severity score of 4. False positive results in a COVID-19 diagnostic test could lead to inappropriate medical decisions, unnecessary treatments, or delayed proper care.
Plain-English summary
Ellume Ltd. is recalling approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results.
The recalled test kits have been identified as producing a higher rate of false positive results, meaning the tests may show positive results for COVID-19 when the person tested does not actually have the virus. This can lead to unnecessary medical interventions or prevent people from seeking appropriate care.
The recalled kits were distributed in the United States in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington. Consumers who have kits with the affected lot numbers should stop using them and contact their healthcare provider if they have concerns about previous test results.
The recalled product
- Product
- Ellume COVID-19 Home Test
- Manufacturer
- ELLUME LTD
- Hazard
- false-positive
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 (17)
- Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4
- 21047-5
- 21089-1
- 21117-1
- PF06Z-H
- 21099-1
- 21124-1
- 21125-1
- PF03X-H
- PF057-H
- PF05W-H
- PF069-H
- PF06E-H
- PF06N-H
- PG080-H
- PG08H-H
- PH08X-H
Distribution
Distributed in 6 states:
- MN
- NY
- PA
- RI
- UT
- WA
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