RecallRadar

FDA Device recall Z-0738-2024

INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

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

AgencyFDA Device
Recall numberZ-0738-2024
ClassificationClass II
Statusongoing
Initiated2023-10-25
Published2024-01-24
Last updated2026-09-13 11:57 UTC
CompanyPhase Scientific International
DistributionUS

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_infoLot: 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.