Beckman Coulter DxI 9000 Analyzer Recalled for Leaking Wash Buffer Tank
Beckman Coulter is recalling 17 DxI 9000 Access Immunoassay Analyzers due to cracks in the Internal Wash Buffer Tank that can cause leaking, potentially delaying test results and exposing users to chemical and physical hazards.
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: FDA Class II device with potential for physical and chemical hazards and operational disruption. No reported illnesses, injuries, or deaths are documented. The hazard is theoretical rather than realized, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling 17 units of the DxI 9000 Access Immunoassay Analyzer, a diagnostic device used to measure various substances in human body fluids. The recalled analyzers are identified by serial numbers 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282.
The manufacturer discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank, which is part of the Wash Buffer Supply Drawer. These cracks can cause the tank to leak.
This defect can result in delays in reporting patient test results, exposure to physical and chemical hazards for users, and damage to the equipment or surrounding environment. Affected units were distributed in New Hampshire and internationally in Belgium, Egypt, Italy, Poland, and Spain.
If you operate one of these analyzers, contact Beckman Coulter, Inc. for replacement or repair instructions. Do not continue using a device if you notice any signs of leaking from the buffer tank.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 17
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 (18)
- UDI/DI 15099590732103
- Serial Numbers: 300254
- 300256
- 300257
- 300258
- 300259
- 300263
- 300264
- 300266
- 300268
- 300269
- 300270
- 300271
- 300272
- 300273
- 300275
- 300281
- and 300282
Distribution
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