INDICAID COVID-19 Rapid Antigen At-Home Test…

Date

Jan. 24, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Phase Scientific International Limited

Product

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.

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.

Quantity

360 Kits

Codes and lots

Lot: 22S0388-R01, Exp: 05-Apr-2024

Recall started

Oct. 25, 2023

Device type

Covid-19 Multi-Analyte Antigen Device

Root cause (FDA)

Incorrect or no expiration date

What the company told customers

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.

Recall number

Z-0738-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0738-2024. The agency record governs; check it and the company before acting.