FDA recall Z-0738-2024

PHASE SCIENTIFIC INTERNATIONAL LIMITED · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2023-10-25
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sha Tin, N/A, Hong Kong SAR

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0738-2024