Access Intact PTH Assay (Beckman Coulter) – Sample Storage Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 15099590201937 Lots 338921 339071 372223 439138 439205 439206 439207 439650 439801 439889 440026 440090 472012 472092 472136 472154
Beckman Coulter Inc. is recalling Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 8, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL letters that the affected assay may produce falsely decreased results if EDTA and lithium heparin plasma samples are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the test. Access Intact PTH assay Routine Mode and Intraoperative Mode users can select any of the following options: . Use serum as the sample type. . Perform testing on an alternate methodology, such as the Access 2 or UniCel DxI 600 or 800 Immunoassay Analyzers. . Continue to use EDTA and/or lithium heparin plasma sample types if the tests are completed within the timeframes listed below upon sample presentation to the DxI 9000 Access Immunoassay Analyzer (see page 3 for instructions): o Access Intact PTH assay Routine Mode: 25 minutes. o Access Intact PTH assay Intraoperative Mode: 20 minutes. . Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from Access Intact PTH Routine Mode plasma samples on the DxI 9000 to determine if retesting is necessary.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026