PHASE SCIENTIFIC INTERNATIONAL LIMITED recalls INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

Recall date

October 25, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0738-2024

FDA classification

Class II

Brand / firm

PHASE SCIENTIFIC INTERNATIONAL LIMITED

Sold / distributed

US Nationwide distribution including in the states of CA, NY, VT, WA, OH, MD , NJ, PA, MS, NC, AL, MI, MA, DE, GA, TX, OR, MO , WI , ME, IL, VA, CO, NM, NH, LA, KY, DC, MN, MO, FL, AR, MD, TN, UT, WY, SC, WI, CT, KS, SD.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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