Recall Z-0738-2024
Phase Scientific International Limited · initiated October 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Codes / lots: Lot: 22S0388-R01, Exp: 05-Apr-2024
Reason for recall
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.
FDA-determined cause: Incorrect or no expiration date
Action taken
On 10/25/23, recall notices were mailed to customers who were asked to do the following: 1) Return remaining unused product. 2) Complete and return the response card. Customers with recall-related questions can contact the firm at care@indicaidusa.com or via phone at 800-875-6906.
Details
- Recall number
- Z-0738-2024
- Initiated
- October 25, 2023
- Posted by FDA
- January 17, 2024
- Product code
- QMN – Covid-19 Multi-Analyte Antigen Device
- Quantity
- 360 Kits
- 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.
- Recalling firm
- Phase Scientific International Limited, Sha Tin