Recall Z-1115-2025— Beckman Coulter, Inc.
Class II · Completed
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2024-01-03. It names one FDA 510(k) clearance: K221225. Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument. Reason: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2024-01-03
- Firm location
- Chaska, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Reason for recall
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.