The Recall Desk
ModerateFDA (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.

What this means for you

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
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:

Related recalls

Same manufacturer · Beckman Coulter, Inc.

See all →

Same hazard · component defect

See all →