FDA Device recall Z-0738-2024
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 by Phase Scientific International, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0738-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-25 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Phase Scientific International |
| Distribution | US |
Product
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Reason
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.
Identifiers
| code_info | Lot: 22S0388-R01, Exp: 05-Apr-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0738-2024%22
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