Chemistry analyzers recalled over gantry defect that pauses the instrument
Beckman Coulter is recalling 657 UniCel DxI 800 analyzers because defective gantry sub-components can cause a z-axis motion error that halts the analyzer and delays results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: an analyzer halting mid-run delays patient results, and no injuries are reported.
Plain-English summary
The Beckman Coulter UniCel DxI 800 photometric chemistry analyzer, part numbers 973100 and A71456, is being recalled.
An internal investigation 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 recall covers 657 units, including UDI/DI 15099590265373, distributed worldwide. The FDA has classified the action as Class II.
The enforcement record describes the fault and reports no injuries. Laboratories operating an affected analyzer should follow Beckman Coulter's instructions.
The recalled product
- Product
- Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 657
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.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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