—#211080

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.

FDA product code: CEW — Radioimmunoassay, Parathyroid Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K232791
Affected lot / code info: UDI-DI 15099590201937 Lots 338921 339071 372223 439138 439205 439206 439207 439650 439801 439889 440026 440090 472012 472092 472136 472154

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, Egypt, France, Germany, Ghana, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, S. Korea, Spain, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.

Timeline

Recall initiated: 2024-11-08
Posted by FDA: 2024-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.