Beckman Coulter Analyzer Recalled for Pneumatic Tubing Defects
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed 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: FDA Class II device with a functional defect that poses a risk of inaccurate test results in a clinical setting, but no reported illnesses or injuries. Per the severity rubric, risk-of-harm products without reported injury cases score High (3).
Plain-English summary
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (Model C21510, RSM Pneumatic Tubing Kit item #2, REF C11137), an in vitro diagnostic instrument used in clinical laboratories. Approximately 170 units have been distributed worldwide.
The recall was triggered by undersized pneumatic tubing in the reagent storage module. This defect can cause air leaks, compressor failures, or errors in sample processing, potentially leading to inaccurate test results or delayed reporting. Beckman Coulter received four complaints about this issue before discovering undersized tubing in their stock and initiating corrective actions.
Affected devices have been distributed throughout the United States and to customers in Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. Users should contact Beckman Coulter for replacement tubing or remediation instructions if their device's serial number is listed in the recall notice.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 170
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 15099590230623
- Serial Numbers: 300116
- 300117
- 300118
- 300123
- 300126
- 300128
- 300129
- 300130
- 300131
- 300133
- 300134
- 300135
- 300136
- 300137
- 300138
- 300139
- 300141
- 300142
- 300143
Distribution
Distributed nationwide across the United States.
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