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
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