FDA Medical Device Recalls (openFDA)
PHASE SCIENTIFIC INTERNATIONAL LIMITED: INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
- Recall number
- Z-0738-2024
- Recalling firm
- PHASE SCIENTIFIC INTERNATIONAL LIMITED
- Product
- INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
- Status
- Open, Classified
- Initiated
- 2023-10-25
- Posted
- 2024-01-17
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Lot: 22S0388-R01, Exp: 05-Apr-2024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QMN
- Firm FEI
- 3017887566
- Firm city
- Sha Tin
- Firm state
- not on file
- Firm country
- Hong Kong SAR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28