FDA Recall Open, Classified

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

Recall: Z-0738-2024 · Initiated October 25, 2023

Recall

Recall Number
Z-0738-2024
Event Number
93626
Firm
PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR
FEI Number
3017887566
Product Code
QMN
Status
Open, Classified
Root Cause
Incorrect or no expiration date
Initiated
October 25, 2023
Posted
January 17, 2024

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.

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 [email protected] or via phone at 800-875-6906.

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