Medical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results
Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The assay is a Class II medical device where stored samples may produce falsely low results, potentially causing missed diagnosis or delayed treatment. No illnesses or injuries have been reported, but the risk of diagnostic error in managing parathyroid disorders is significant.
Plain-English summary
Beckman Coulter Inc. is recalling the Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer (Catalog number A16972). This diagnostic assay measures parathyroid hormone levels in blood samples.
The FDA has determined that EDTA and lithium heparin plasma samples stored on the analyzer sample wheel for extended periods before testing may produce falsely decreased parathyroid hormone results. These inaccurate test results could lead to missed diagnosis, delayed treatment, or inappropriate clinical management depending on the patient's condition.
The recall affects 31 analyzer systems distributed in the United States and 167 systems distributed internationally, including countries across Europe, Asia, Africa, and Oceania. Specific affected lot numbers are documented in the FDA recall notice.
Healthcare organizations using this assay should contact Beckman Coulter for guidance regarding affected equipment and lot numbers to ensure the accuracy of patient test results.
The recalled product
- Product
- Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- false-test-results
- missed-diagnosis
Distribution
Distribution scope not specified by the agency.
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