DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.
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: The device malfunction poses a risk of harm through diagnostic delays in patient testing. Although this is a Class II recall with no reported injuries or deaths, the explicit statement of 'high safety risk' and the potential for delayed patient results in clinical laboratory settings meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Beckman Coulter, Inc. is recalling the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137) distributed nationwide and globally. The analyzer is used in clinical laboratories to perform immunoassays for patient testing.
The recall is due to a misalignment of the encoder wheel on the motor shaft in certain units. This misalignment can lead to increased slippage errors, causing the instrument to stop functioning. When the analyzer stops, patient test results are delayed, posing a high safety risk to patients who depend on timely diagnostic information.
The affected units are identified by specific serial numbers listed in the recall notice. Healthcare facilities using affected instruments should immediately contact Beckman Coulter or their service representatives. Corrective action and replacement devices are available from the manufacturer.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- device-malfunction
- diagnostic-delay
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)
- UDI-DI: 15099590732103
- Serial Numbers: 300116-300117
- 300123-300124
- 300126
- 300128-300139
- 300141-300145
- 300147- 300158
- 300160-300164
- 300166-300179
- 300181-300183
- 300186
- 300188-300195
- 300197-300207
- 300209-300250
- 300252- 300256
- 300258-300259
- 300261
- 300263- 300264
- 300266-300277
- 300279-300290
Distribution
Distributed nationwide across the United States.
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