Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Pending LLM rewrite. Source: FDA_DEVICE Z-0428-2026.
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
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
The recalled product
- Product
- Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- A71460
- UDI/DI 15099590369224
- Serial Numbers: 902515
- 902529
- 902528
- 902534
- 902526
- 902527
- 902523
- 902522
- 902524
- 902505
- 902578
- 902579
- 902545
- 902530
- 902531
- 902581
- 902504
- 902514
Distribution
Distribution scope not specified by the agency.
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