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Access 2 immunoassay analyzers

Official notice

19 Feb 2025

Last checked

19 Feb 2025

Medium riskHealth Canada

An official Health Canada notice concerns Access 2 immunoassay analyzers. Beckman Coulter has determined that the sample motor on the affected Access 2 Immunoassay analyzers may have an improper alignment to the sample wheel that may result in irregular motion as the sample carousel turns. The irregular motion has the potential to cause damage to the sample wheel motor and/or the sample wheel index sensor over time and can cause an increase in "sample carousel motion error" event messages. After a "sample carousel motion error" occurs, if the analyzer cannot recover from the motion error upon reinitialization, there may be a delay in reporting patient test results to the physician. Recall start date: February 3, 2025 Published 2025-02-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76977

Official notice

2025-02-19

The hazard

Beckman Coulter has determined that the sample motor on the affected Access 2 Immunoassay analyzers may have an improper alignment to the sample wheel that may result in irregular motion as the sample carousel turns. The irregular motion has the potential to cause damage to the sample wheel motor and/or the sample wheel index sensor over time and can cause an increase in "sample carousel motion error" event messages. After a "sample carousel motion error" occurs, if the analyzer cannot recover from the motion error upon reinitialization, there may be a delay in reporting patient test results to the physician. Recall start date: February 3, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76977

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Affected products

Product 1

Affected products - Access System Access 2 Analyzer - Class 2, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 81600N

Product 2

Affected products - Access Immunoassay System - Analyzer Class 3, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 81600N

Product 3

Affected products - Access2 Immunoassay System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 81600N

Risk / hazard

Beckman Coulter has determined that the sample motor on the affected Access 2 Immunoassay analyzers may have an improper alignment to the sample wheel that may result in irregular motion as the sample carousel turns. The irregular motion has the potential to cause damage to the sample wheel motor and/or the sample wheel index sensor over time and can cause an increase in "sample carousel motion error" event messages. After a "sample carousel motion error" occurs, if the analyzer cannot recover from the motion error upon reinitialization, there may be a delay in reporting patient test results to the physician. Recall start date: February 3, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter, Access 2 Immunoassay Analyzers.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76977

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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