Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0269-2023·Announced 2022-11-30

MicroScan autoSCAN-4 Instrument Recall Due to Incorrect Diffuser Plate

Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.

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: This is an FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The recall addresses a manufacturing defect without any documented adverse clinical events, making it a precautionary recall classified as Moderate severity.

Plain-English summary

Beckman Coulter, Inc., is recalling MicroScan autoSCAN-4 Instruments, Catalog Number B1018-280, due to manufacturing with an incorrect diffuser plate component.

The affected instruments were distributed worldwide. In the United States, distribution included Alaska, Florida, Iowa, Idaho, Michigan, Mississippi, Montana, North Carolina, Nebraska, Pennsylvania, South Carolina, Texas, Washington, Wisconsin, and West Virginia. International distribution included Chile, Germany, Indonesia, Italy, Japan, Mexico, Peru, Portugal, South Africa, Spain, the United Kingdom, and Uruguay.

Customers who have received affected units should contact Beckman Coulter for guidance on corrective actions. Affected instruments may be identified using the provided serial numbers or UDI-DI Code 15099590658625.

The recalled product

Product: MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Manufacturer: Beckman Coulter, Inc.
Category: Medical Device — Laboratory Instrument
Hazard: component-defect
Affected units: 53

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 (20)

400496
400497
400498
400499
400500
400503
400504
400506
400507
400508
400509 400510
400511
400512
400513
400514
400515
400516
400517
400518
400519

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Same manufacturer · Beckman Coulter, Inc.

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