Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers
Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.
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 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: The recall is classified as FDA Class II, and the hazard involves potential inaccuracy of test results rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Beckman Coulter Inc. is recalling ISE REF Valves, Part No. MU3226, used in AU400, AU640, AU2700, and AU5400 Chemistry Analyzers. The recall was initiated because the company confirmed that some ISE units can experience premature failure of the ISE REF (Reference) valve.
Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, the accuracy of the ISE test results may be affected.
A total of 4,584 units were distributed, with 1,173 units in the United States. The product was distributed nationwide in the US as well as in Canada, Vietnam, Zambia, and Zimbabwe. Users should check their ISE units for air bubbles in the ISE REF solution tubing to detect potential valve failure.
The recalled product
- Product
- ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- AU400
- Item Code: 5427300 5427900 N1257700 AU640
- Item Code: 590220 5902400 A92928 A92929 AU2700
- Item Code: 5996100 N3156700 N9025844 AU5400 OPA
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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