The Recall Desk
Severity pendingFDA (Devices)·Z-0428-2026·Announced 2025-11-12

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.

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.