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U.S. Department of Health and Human Services

Class 2 Device Recall INDICAID COVID19 Rapid Antigen AtHome Test

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  Class 2 Device Recall INDICAID COVID19 Rapid Antigen AtHome Test see related information
Date Initiated by Firm October 25, 2023
Date Posted January 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-0738-2024
Recall Event ID 93626
Product Classification COVID-19 Multi-Analyte Antigen Device - Product Code QMN
Product INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Code Information Lot: 22S0388-R01, Exp: 05-Apr-2024
Recalling Firm/
Manufacturer		 PHASE SCIENTIFIC INTERNATIONAL LIMITED
1/f, E Phase 3
Hong Kong Science Park
Sha Tin Hong Kong SAR
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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