FDAFDA · Food and drugs·Recall number Z-0738-2024
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Published January 24, 2024 · Recall initiated: October 25, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHASE SCIENTIFIC INTERNATIONAL LIMITED
- Distributor
- 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.
- Lot
- Lot: 22S0388-R01, Exp: 05-Apr-2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Hong Kong SAR
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