COVID-19 Rapid Antigen Test Recalled for Incorrect Expiration Date Labeling
INDICAID COVID-19 Rapid Antigen At-Home Tests were released with an incorrect expiration date (05 April 2024) instead of the correct date (21 February 2024). Expired tests may produce inaccurate or invalid results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product recall with no reported illnesses or injuries. The hazard is that expired tests could produce inaccurate or invalid results, which could lead to incorrect health decisions. While FDA Class II, the functional integrity issue of an expired diagnostic test supports a High severity rating per the rubric criterion for theoretical risk-of-harm.
Plain-English summary
PHASE SCIENTIFIC INTERNATIONAL LIMITED issued a recall of the INDICAID COVID-19 Rapid Antigen At-Home Test (REF: P0040) distributed across the United States. Approximately 360 kits with lot number 22S0388-R01 were released with an incorrect expiration date printed on the packaging.
The tests were labeled with an expiration date of 05 April 2024, but the correct expiration date is 21 February 2024. Using expired COVID-19 tests could result in inaccurate or invalid test results, which may lead to incorrect health decisions.
Consumers who purchased these tests are advised to stop using them if they have lot number 22S0388-R01, particularly those purchased after 21 February 2024. Consumers should contact the manufacturer or their healthcare provider for testing alternatives.
The recalled product
- Product
- INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
- Manufacturer
- PHASE SCIENTIFIC INTERNATIONAL LIMITED
- Category
- Medical Device — Diagnostic Test
- Affected units
- 360
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 (2)
- Lot: 22S0388-R01
- Exp: 05-Apr-2024
Distribution
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