Beckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.
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: This is an FDA Class II medical device with a mechanical defect that prevents proper operation. No injuries or illnesses are mentioned in the recall notice. The defect can disrupt laboratory testing and delay patient results, meeting the Score 3 criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling certain units of the DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, due to a mechanical defect in the wash wheel mixer. Approximately 245 units are affected, distributed nationwide in the United States and globally.
The wash wheel mixer in the affected units may not spin freely within the idler pulley housing. When this problem occurs, the analyzer displays a 'Wash Wheel Dispense Arm Spin Mixer Error' on the user interface and enters a red system status with a system flag. The analyzer may cancel tests in progress, which can cause delays in reporting laboratory results to patients.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 245
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 (1)
- UDI-DI: 15099590732103
Distribution
Distributed nationwide across the United States.
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