Beckman Coulter Access 2 Immunoassay System Analyzer Recalled for Non-Conforming Bushings
Beckman Coulter is recalling three Access 2 Immunoassay System Analyzers because non-conforming bushings may generate incorrect results.
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 source text describes the risk as having a 'remote probability' of generating incorrect results without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling three units of the Access 2 Immunoassay System Analyzer. The recall is due to the possibility that the devices were manufactured with non-conforming bushings.
The Access 2 Immunoassay System is an in vitro diagnostic device used to determine analyte concentrations in human body fluids. According to the source text, non-conforming bushings have a remote probability of generating incorrect results. The affected units are identified by Part Number 81600N and Serial Numbers 508957, 508963, and 508964.
The recall covers distribution in South Dakota, Germany, Lebanon, and China. The source text does not specify instructions for consumers or healthcare facilities regarding the return or replacement of these specific units.
The recalled product
- Product
- Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 3
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 (3)
- Part Number 81600N. Serial Numbers 508957
- 508963
- 508964.
Distribution
Distributed in 1 state:
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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