Recall MonitorHealth Products
Access 2 Immunoassay Analyzers
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Access 2 Immunoassay Analyzers
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Access System Access 2 Analyzer - Class 2 | More than 10 numbers, contact manufacturer. | 81600N |
| Access Immunoassay System - Analyzer Class 3 | More than 10 numbers, contact manufacturer. | 81600N |
| Access2 Immunoassay System | More than 10 numbers, contact manufacturer. | 81600N |
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