Siemens Healthcare Diagnostics is recalling several lots of Atellica and ADVIA Centaur CA 19-9 diagnostic test kits used to measure tumor-associated antigens in human serum. These tests may produce a "positive bias," meaning they could show falsely elevated results near the normal upper limit of 35 U/mL, particularly in patients from Asia Pacific populations. These kits were distributed nationwide across the United States and internationally.
A positive bias in these diagnostic tests can lead to falsely elevated results, which may cause healthcare providers to misinterpret a patient's condition, potentially leading to unnecessary follow-up testing or incorrect clinical management decisions.
Manufacturer Notification and Technical 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.
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Sources: FDA iRES · Raw API Response
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