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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

PHASE SCIENTIFIC INTERNATIONAL LIMITED: INDICAID COVID-19 Rapid Antigen At-Home Test Recalled for Incorrect Expiration

Agency Publication Date: January 17, 2024
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Summary

Approximately 360 INDICAID COVID-19 Rapid Antigen At-Home Test kits (REF: P0040) are being recalled because they were labeled with an incorrect expiration date of April 5, 2024. The actual expiration date for these tests was February 21, 2024. Consumers may unknowingly use an expired test, which can lead to false or unreliable results. These kits were distributed nationwide to several states including California, New York, Texas, and Florida.

Risk

Expired diagnostic tests may have degraded reagents that fail to accurately detect the virus, potentially leading to incorrect negative results or invalid readings. This could cause individuals to delay seeking medical treatment or inadvertently spread COVID-19 to others.

What You Should Do

  1. Check your INDICAID COVID-19 Rapid Antigen At-Home Test kit for REF number P0040 and Lot number 22S0388-R01.
  2. Look at the expiration date printed on the packaging; affected tests will show an incorrect date of 05-Apr-2024.
  3. Stop using tests from Lot 22S0388-R01 immediately, as they expired on February 21, 2024, despite the printed date.
  4. Contact your healthcare provider or the manufacturer, Phase Scientific International Limited, for further instructions regarding replacement or potential refund for the affected test kits.
  5. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer and Healthcare Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Model / REF:
P0040
Lot Numbers:
22S0388-R01 (Exp: 05-Apr-2024)
Date Ranges: Expired 21-Feb-2024, Labeled Exp: 05-Apr-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93626
Status: Active
Manufacturer: PHASE SCIENTIFIC INTERNATIONAL LIMITED
Sold By: US Nationwide distribution
Manufactured In: Hong Kong SAR
Units Affected: 360 Kits
Distributed To: California, New York, Vermont, Washington, Ohio, Maryland, New Jersey, Pennsylvania, Mississippi, North Carolina, Alabama, Michigan, Massachusetts, Delaware, Georgia, Texas, Oregon, Missouri, Wisconsin, Maine, Illinois, Virginia, Colorado, New Mexico, New Hampshire, Louisiana, Kentucky, District of Columbia, Minnesota, Florida, Arkansas, Tennessee, Utah, Wyoming, South Carolina, Connecticut, Kansas, South Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.