Beckman Coulter AutoMate 2500 Family Recalled for Operating System Update
Beckman Coulter is recalling four AutoMate 2500 Family units in Maryland to update the PC image for Windows 10 compatibility.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 a voluntary precautionary recall for a software/operating system update with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc. is recalling four units of the AutoMate 2500 Family, including the AutoMate 1200, 1250, 2500, and 2550 models. These devices are semi-open, pre- and post-analytical sample processing and sorting systems used to automate sample sorting, decapping, and archiving.
The recall was initiated to implement a design change that updates the Automate PC image to accommodate an operating system change to Windows 10. The affected units were distributed to Maryland only. Specific unit codes include ODL25255-4437, ODL25255-4443, ODL25255-4444, and ODL25255-4438.
This action is a precautionary measure to ensure the devices function correctly with the updated operating system. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 4
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)
- ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438
Distribution
Distributed in 1 state:
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