Beckman Coulter Recalls AU2700 and AU5400 Clinical Chemistry Analyzers
Beckman Coulter is recalling AU2700 and AU5400 Clinical Chemistry Analyzers because tubing connections may leak concentrated detergent.
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 involves a risk-of-harm product (leaking concentrated detergent) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling AU2700 and AU5400 Clinical Chemistry Analyzers. These devices are used to perform automated analysis of serum, urine, and other body fluids, including whole blood.
The recall is being conducted because the tubing and joint connections associated with these devices may leak concentrated detergent. The company has received complaints that the joint connecting the tubing appears to disintegrate over time, which causes the leak.
The recall affects 108 units distributed worldwide, including the United States, Australia, Canada, Germany, Spain, Great Britain, Italy, Portugal, and Japan. Users should contact Beckman Coulter for instructions on how to address the defect.
The recalled product
- Product
- AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 108
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 (4)
- All Serial Numbers Model Numbers: AU2700
- AU27000ISE
- AU5421
- AU5421ISE
Distribution
Distributed nationwide across the United States.
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