# FDA recall Z-2264-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-04-18.

## Product

DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

## Reason for recall

Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk 

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2264-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-18
- **Report date:** 2024-07-10

- **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-2264-2024

## Citation

> AI Analytics. FDA recall Z-2264-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2264-2024. Source: US FDA. Licensed CC0.

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