Class II

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

PHASE SCIENTIFIC INTERNATIONAL LIMITED · October 25, 2023

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

360 Kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0738-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

PHASE SCIENTIFIC INTERNATIONAL LIMITED Medical Device Recall: INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 | SafeCheck