Siemens Healthcare Diagnostics, Inc. has recalled 7,332 units of the IMMULITE 2000 PSA assay due to a defect where the test may produce inaccurate results when used to measure extremely high levels of prostate-specific antigen (PSA). The assays fail to meet the "High-dose Hook Effect" claim in their instructions, which is meant to ensure accuracy even at high concentrations. No injuries or incidents have been reported, but these diagnostic kits, used in healthcare facilities and laboratories nationwide, may provide incorrect data to clinicians.
The defect can cause the assay to report falsely low PSA levels in patients who actually have very high concentrations, potentially leading to a delayed diagnosis or incorrect management of prostate conditions.
Correction or Replacement
Firm initiated recall.
Firm initiated recall.
Distributed outside the United States but included in firm notification.
Distributed outside the United States but included in firm notification.
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.
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 · Raw API Response
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