---
title: "DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnost... — FDA record Z-1529-2025 | Is It on Recall"
description: "Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipmen"
url: https://isitonrecall.com/recall/fda-device-z-1529-2025-dxi-9000-access-immunoassay-analyzer-catalog-number-c11137-in-vitro-diagnostic-device-used-for-the-q/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, sem... — FDA record Z-1529-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 12, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
- **Reason**: Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
- **Classification**: Class II
- **Recalling firm**: Beckman Coulter, Inc.
- **Quantity**: 30 OUS
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1529-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1529-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI 15099590732103 Serial/Lot Numbers: 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, and 300156 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 16, 2025
- **Recall initiation date**: Jul 12, 2024
- **Center classification date**: Apr 4, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1529-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Beckman Coulter Inc. records](https://isitonrecall.com/brand/beckman-coulter-inc/)