[pending] Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Pending LLM rewrite. Source: FDA_DEVICE Z-0429-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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