Beckman Coulter recalls Access Intact PTH assay for DxI 9000 analyzer due to false low parathyroid hormone results from prolonged sample storage. This may cause missed diagnoses or delayed treatment.
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.
Beckman Coulter is recalling the Access Intact PTH assay for the DxI 9000 Access Immunoassay Analyzer. Storing plasma samples in the sample wheel for too long before testing can cause false low parathyroid hormone results, which might lead to missed diagnoses or delayed treatment.
Plasma samples stored in the sample wheel for extended periods before testing can cause the assay to show falsely decreased parathyroid hormone levels. This may result in missed diagnoses or delayed treatment depending on the patient's condition.
Healthcare providers using the Access Intact PTH assay on the DxI 9000 analyzer are affected. Patients with parathyroid hormone testing needs are at risk if the assay produces false low results.
Check for the catalog number A16972 on the Access Intact PTH assay. The product was sold with specific lots: 338921, 339071, 372223, 439138, 439205, 439206, 439207, 439650, 439801, 439889, 440026, 440090, 472012, 472092, 472136, 472154.
Verify the lot numbers on your Access Intact PTH assay to see if they match the recalled lots: 338921, 339071, 372223, 439138, 439205, 439206, 439207, 439650, 439801, 439889, 440026, 440090, 472012, 472092, 472136, 472154.
The recall is because storing plasma samples in the sample wheel for too long before testing can cause false low parathyroid hormone results, which might lead to missed diagnoses or delayed treatment.
Check the lot numbers on your Access Intact PTH assay to see if they match the recalled lots. If they do, you may need to contact Beckman Coulter for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0673-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0673-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
