Beckman Coulter AutoMate Systems Recalled for Premature Belt Failure
Beckman Coulter is recalling AutoMate 1200, 1250, 2500, and 2550 systems due to premature belt failure that poses a remote risk of cross-contamination.
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 cross-contamination, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling specific AutoMate 1200, 1250, 2500, and 2550 systems. The recall involves 98 units in the United States and distribution in numerous other countries. The affected units are identified by specific catalog numbers and serial number limits provided in the agency data.
The recall is being conducted because belts on the x-axis, and to a lesser extent the y-axis, manufactured from 2015 are showing premature failure. This defect poses a remote risk of cross-contamination. The FDA has classified this as a Class II recall.
Users of these systems should contact Beckman Coulter Inc. for further instructions on how to address the defect.
The recalled product
- Product
- AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 98
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 (8)
- All systems up to the following Serial Numbers: ODL25120 Revision T
- SN3101
- ODL25125 Revision W
- SN1508
- ODL25250 Revision T
- SN2416
- ODL25255 Revision W
- SN4617
Distribution
Distribution scope not specified by the agency.
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