# FDA recall Z-0673-2025

> **Beckman Coulter Inc.** · Class II · device recall initiated 2024-11-08.

## 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 for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0673-2025
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-08
- **Report date:** 2024-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0673-2025

## Citation

> AI Analytics. FDA recall Z-0673-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0673-2025. Source: US FDA. Licensed CC0.

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