Beckman Coulter AutoMate 1250 and 2550 Sample Processing System Recall
Beckman Coulter is recalling AutoMate 1250 and 2550 systems due to a risk of sample misidentification caused by duplicate barcode labels.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of sample misidentification, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling the AutoMate 1250 and AutoMate 2550 sample processing and sorting systems, identified by part numbers ODL25125 and ODL25255. The recall involves 468 units total, with 51 units distributed in the United States and the remainder distributed worldwide across 34 other countries. All serial numbers are affected.
The recall was initiated after the manufacturer confirmed customer reports that secondary tubes were being labeled with two different barcode labels. This defect can cause the misidentification of a sample when software versions lower than version 4.1 are used. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing system that automates sample sorting, decapping, and archiving.
The FDA has classified this as a Class II recall. Users of these systems should contact Beckman Coulter for instructions on how to resolve the labeling issue and ensure sample integrity.
The recalled product
- Product
- AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling…
- Manufacturer
- Beckman Coulter Inc.
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)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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