Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0738-2024

October 25, 2023

Class II

Product summary

Firm
PHASE SCIENTIFIC INTERNATIONAL LIMITED
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

    reason.no_named_rule · v1.0.0

    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.