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.
- Hazard
- component-defect
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.
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