# FDA recall Z-0107-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2023-09-12.

## Product

DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

## Reason for recall

The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with  the results of sample B.

## Distribution

Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.

## Key facts

- **Recall number:** Z-0107-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-12
- **Report date:** 2023-10-18

- **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-0107-2024

## Citation

> AI Analytics. FDA recall Z-0107-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0107-2024. Source: US FDA. Licensed CC0.

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