# FDA recall Z-0982-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2023-11-21.

## Product

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

## Reason for recall

There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion  factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to  report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

## Key facts

- **Recall number:** Z-0982-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-21
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2024

## Citation

> AI Analytics. FDA recall Z-0982-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0982-2024. Source: US FDA. Licensed CC0.

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