Immunotech A.S. has recalled 160 units of Estrone RIA (radioimmunoassay) diagnostic kits because certain batches may provide falsely high patient results. These incorrect measurements could lead to improper clinical decisions and temporary health injuries, although the manufacturer indicates this issue occurs only in very rare cases. The affected kits were distributed worldwide, including North Carolina in the United States, between December 2025 and February 2026.
A falsely high estrone level result could lead to incorrect diagnosis or treatment plans. While the probability is remote, this defect poses a risk of temporary injury to patients due to medical mismanagement based on inaccurate laboratory data.
Recall #: Z-1369-2026; Firm FEINUM: 3003385757
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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