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Health Canada Medical devices

Access 2 Immunoassay Analyzers

Issued February 19, 2025
Issue
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
Hazard description
Performance
Product
Product name
Access 2 Immunoassay Analyzers
Reference
ID
RA-76977