FDA Enforcement
Class II
Ongoing
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Recall: Z-0738-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0738-2024
- Event ID
- 93626
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHASE SCIENTIFIC INTERNATIONAL LIMITED
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- October 25, 2023
- Classification Date
- January 17, 2024
- Address
- 1/f, E Phase 3, Hong Kong Science Park, Sha Tin, N/A, N/A, Hong Kong SAR
Description
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
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 Info
Lot: 22S0388-R01, Exp: 05-Apr-2024
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.
Quantity
360 Kits