DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Reported: March 19, 2025 Initiated: November 13, 2024 #Z-1326-2025
Product Description
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Reason for Recall
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 245 units
- Distribution
- US Nationwide. Global Distribution.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. Recalled by Beckman Coulter, Inc.. Units affected: 245 units.
Why was this product recalled? ▼
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2025. Severity: Moderate. Recall number: Z-1326-2025.
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