Beckman Coulter Inc. is recalling the Access Intact PTH assay used on the DxI 9000 Access Immunoassay Analyzer because it can produce falsely low parathyroid hormone (PTH) test results. This issue occurs when plasma samples are stored on the analyzer's sample wheel for too long before testing. Approximately 31 units in the U.S. and 167 units internationally are affected, though no injuries or incidents have been reported to date. Laboratory professionals should identify affected lot numbers and contact the manufacturer for corrective instructions.
A falsely decreased parathyroid hormone result could lead to a missed diagnosis, a delay in starting necessary treatment, or incorrect clinical management of a patient's condition. This risk is particularly high if the lab result is used as the primary factor in medical decision-making.
Quantity affected: 31 US; 167 OUS. Used for the quantitative determination of intact parathyroid hormone levels in human serum and plasma.
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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