Device product
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Z-0738-2024
Product summary
- Event
- Event 93626
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 360 Kits
- Official record key
device-enforcement:Z-0738-2024
Official wording
Reason: 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.
Code information: Lot: 22S0388-R01, Exp: 05-Apr-2024
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.