# FDA recall Z-2544-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-05-22.

## Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

## Reason for recall

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS.  This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, and TX. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.

## Key facts

- **Recall number:** Z-2544-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-22
- **Report date:** 2024-08-21

- **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-2544-2024

## Citation

> AI Analytics. FDA recall Z-2544-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2544-2024. Source: US FDA. Licensed CC0.

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