Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
- Recall date
- February 5, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1388-2025
- FDA classification
- Class II
- Brand / firm
- Beckman Coulter, Inc.
- Sold / distributed
- US Nationwide. Global Distribution.
Why it was recalled
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Get recall alerts
Free email alert whenever Beckman Coulter, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Beckman Coulter, Inc.