Siemens Healthcare Diagnostics is recalling approximately 3,284 packs of Atellica IM Homocysteine Calibrators and ADVIA Centaur HCY Calibrators. These products are being recalled because certain lots have shown instability, which can lead to incorrect laboratory test results. The affected products were distributed worldwide, including nationwide across the United States, between April and May 2025.
The calibrators can become unstable over time, resulting in an increased positive bias, meaning test results may appear higher than they actually are. This poses a risk of incorrect patient diagnosis or medical management based on inaccurate lab data.
Manufacturer correction or return
Quantities: 2,212 packs total (448 US, 1,764 OUS)
Quantities: 1,072 packs total (156 US, 916 OUS)
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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