# FDA recall Z-2602-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-07-21.

## Product

DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

## Reason for recall

There is a potential that sample carriers (w or w/o samples) within automated sampling system  may transport samples to the outer lane  which does not contain a physical barrier to restrain samples.   Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).

## Distribution

US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV.

## Key facts

- **Recall number:** Z-2602-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-21
- **Report date:** 2021-10-06
- **Termination date:** 2024-10-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2021

## Citation

> AI Analytics. FDA recall Z-2602-2021. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2602-2021. Source: US FDA. Licensed CC0.

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