Z-0738-2024Class II

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

Name: Z-0738-2024 INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Creator: Phase Scientific International Limited
Published: 2023-10-25
License: https://open.fda.gov/license/

Phase Scientific International Limited / initiated 2023-10-25 / Open, Classified

FDA source

PHASE SCIENTIFIC INTERNATIONAL LIMITED began a recall of INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 on 2023-10-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0738-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-25
Posted: 2024-01-17
Recalling firm: Phase Scientific International Limited
Product: INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Product code: QMN Covid-19 Multi-Analyte Antigen Device
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 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 [email protected] 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.
Product codes and lots: Lot: 22S0388-R01, Exp: 05-Apr-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0738-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0738-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17

Product code QMN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)