# FDA recall Z-2145-2023

> **Beckman Coulter Biomedical GmbH** · Class II · device recall initiated 2023-06-02.

## Product

Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ,  RxOnly

## Reason for recall

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

## Distribution

US: AL	CA	FL	IL	IN	KY	MI	MN	MO	NE	NJ	NV	NY	OH	PA	SC	TX	WI	WV  OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,

## Key facts

- **Recall number:** Z-2145-2023
- **Recalling firm:** Beckman Coulter Biomedical GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-02
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munchen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2145-2023

## Citation

> AI Analytics. FDA recall Z-2145-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2145-2023. Source: US FDA. Licensed CC0.

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