Recall Z-0738-2024 ยท QMN Covid-19 Multi-Analyte Antigen Device
PHASE SCIENTIFIC INTERNATIONAL LIMITED
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
| Date | Jan 17, 2024 (initiated Oct 25, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Incorrect or no expiration date |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.