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Open, Classified

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

FDA Recall Z-0738-2024 · Posted 2024-01-17

Recalling FirmPHASE SCIENTIFIC INTERNATIONAL LIMITED
Recall StatusOpen, Classified
Product CodeQMN
Date Initiated2023-10-25
Product Quantity360 Kits

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.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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