Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands
Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test 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 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: FDA Class II medical device recall affecting equipment used directly in patient diagnostics. The defect presents a risk of harm through potential erroneous patient test results, which could affect clinical decision-making. No illnesses or injuries have been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling four models of Access Immunoassay Analyzers: Access 2 Immunoassay Analyzer (PN 81600N), Access 2 Immunoassay Analyzer Refurbished (PN 386220), Access 2 Immunoassay Analyzer Refurbished (PN A65531), and Access 2 Section DxC 600i Packaged (PN A25640). Affected units include 990 devices in the United States and 3,147 distributed internationally, for a total of 4,137 recalled devices.
The recall is due to defective nut band components supplied by a new vendor, Boamax. These nut bands do not meet Beckman Coulter's specifications for hardness and have incorrect material grain direction. The defects can cause wash arm motion failures, system check failures, and reduced assay performance, which may result in delayed test results or erroneous patient test results.
Affected analyzers were manufactured between December 28, 2017 and October 19, 2022, or had their nut bands replaced during this period. Users of these diagnostic instruments should contact Beckman Coulter for instructions on device replacement or repair.
The recalled product
- Product
- Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
- 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)
- DxC 60i Packaged
Distribution
Distributed nationwide across the United States.
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