Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin
Pending LLM rewrite. Source: FDA_DEVICE Z-1025-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
The recalled product
- Product
- Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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