FDA-Device2024-01-24Class II

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

PHASE SCIENTIFIC INTERNATIONAL LIMITED
Hazard

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.

Sold states
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.
Affected count
360 Kits
Manufactured in
1/f, E Phase 3, Hong Kong Science Park, Sha Tin, N/A, Hong Kong SAR
Products
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

Official notice

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

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