INDICAID COVID-19 Rapid Antigen At-Home Test — Class II medical device recall Z-0738-2024
Ongoing recall by PHASE SCIENTIFIC INTERNATIONAL LIMITED, reported 2024-01-24, distributed nationwide. COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the
| Recall number | Z-0738-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHASE SCIENTIFIC INTERNATIONAL LIMITED, Sha Tin, N/A, Hong Kong SAR |
| Recall initiated | 2023-10-25 |
| Classified | 2024-01-17 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 360 kits |
| Reason classes | labeling |
| Lot numbers | 22S0388-R01 |
| Model numbers | P0040 |
| Expiration dates | 2024-04-05 |
Product
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Reason for recall
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0738-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.