Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Pending LLM rewrite. Source: FDA_DEVICE Z-0429-2026.
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 800, Part Numbers: 973100, A71456; 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)
- 973100
- UDI/DI 15099590265373 (Chaska)
- Serial numbers: 610458
- 610455
- 610679
- 610579
- 610432
- 610430
- 610434
- 610664
- 610682
- 610765
- 610500
- 610541
- 610544
- 610545
- 610562
- 610547
- 610585
- 610595
Distribution
Distribution scope not specified by the agency.
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