Beckman Coulter is recalling 362 units of its Access Intact PTH assay, a diagnostic test used by laboratories to measure parathyroid hormone levels in human blood. The recall was initiated because certain reagent packs may be overfilled or underfilled, which can cause the diagnostic instrument to malfunction or produce inaccurate results. While no injuries have been reported, laboratories should stop using the affected reagent packs immediately to avoid potential diagnostic delays or incorrect patient management.
Filling errors in the test reagent can cause the assay to provide inaccurate results or suffer from contamination and sealing issues. Inaccurate hormone measurements may lead to incorrect medical decisions or delays in diagnosing thyroid-related conditions.
Recall Number: Z-0803-2025. Internal non-conformance NC-INT-66585.
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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