Sha Tin, N/A, Hong Kong SAR
PHASE SCIENTIFIC INTERNATIONAL LIMITED recalls
1 recall recorded since 2018, most recently on 25 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 October 2023
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0738-2024
- INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.