Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2983-2020·Announced 2020-09-30

Beckman Coulter Recalls DxA 5000 Automated Sample Handling Systems

Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or significant injuries are reported in the source text, and the hazard is primarily related to confusing instructions and undetected barcode re-use.

Plain-English summary

Beckman Coulter Biomedical GmbH is recalling 32 units of the DxA 5000 automated sample handling system. The recall is due to instructions for use that may be confusing regarding the re-use of sample IDs. The company has received complaints indicating that the re-use of sample barcodes was not being detected by the system.

The affected units were distributed worldwide, including in the United States (specifically Illinois, Ohio, Pennsylvania, and West Virginia) and in Australia, Canada, China, Czech Republic, France, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and the United Kingdom. The recall applies to all serial, lot, and software versions of the product.

Healthcare facilities and users of the DxA 5000 should contact Beckman Coulter for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents…
Manufacturer: Beckman Coulter Biomedical GmbH
Category: Medical Device — Laboratory Automation
Hazard: mis-labeling
software-error
Affected units: 32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Serial/Lot Number(s)/Software Version: all

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Beckman Coulter Biomedical GmbH

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