Recall archive / FDA device enforcement
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative dete... — FDA record Z-0673-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 31 US; 167 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0673-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 15099590201937 Lots 338921 339071 372223 439138 439205 439206 439207 439650 439801 439889 440026 440090 472012 472092 472136 472154 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 18, 2024
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Dec 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.