Ortho-Clinical Diagnostics, Inc. has recalled approximately 455,422 VITROS XT Chemistry Products TBIL-ALKP and ALKP Slides because they may report incorrectly low results for alkaline phosphatase (ALKP) tests. This issue occurs when patient samples have very high levels of ALKP or other interfering substances that exhaust the test's reagents without triggering a system warning code. These products were distributed worldwide, including across the United States, between approximately July 2023 and January 2025.
The system may provide a test result that is significantly lower than the actual value, which can lead to a missed or delayed diagnosis of liver disease or other serious medical conditions. This error happens because the device fails to notify the operator that the test's substrate has been depleted during the reaction.
Manufacturer consultation
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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