Immunostics, Inc. is recalling 10 kits of its Detector H. Pylori (Catalog Number IHP-30) diagnostic tests because the labels incorrectly state the product expires on October 31, 2023. The actual expiration date for these specific lots was October 31, 2022, meaning the product may have been used after it had already expired. Using an expired diagnostic test can lead to false positive, false negative, or otherwise invalid medical results. These kits were distributed to locations in California and Missouri.
The use of expired diagnostic components can compromise the chemical integrity of the test, leading to inaccurate results that could result in improper medical diagnosis or treatment. No specific injuries or incorrect diagnoses have been reported to date.
Manufacturer notification and guidance
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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