Beckman Coulter DxI 9000 Analyzer Tubing Malfunction Causes Test Errors
Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.
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: Class II medical device capable of producing false or delayed test results that could harm patients in acute care settings. No illnesses or injuries have been reported, but this is a risk-of-harm product where equipment malfunction creates potential for delayed medical treatment decisions.
Plain-English summary
Beckman Coulter, Inc. is recalling 9 DxI 9000 Access Immunoassay Analyzer instruments distributed in Indiana and internationally in Italy, Sweden, Ireland, and Spain. These laboratory diagnostic devices quantitatively or qualitatively measure various analytes in human blood and body fluids.
A defect in the pneumatic tubing used in the analytical pick-and-place assembly can disconnect from cable fittings during normal operation. When disconnection occurs, the analyzer may generate system error messages, cancel tests, or enter a red-system error state.
The tubing disconnection also prevents proper ejection of reaction vessels. Unbound reagent may remain on vessel walls instead of being washed away, causing artificially elevated signal readings. This results in false high or false low test results, and may cause tests to be cancelled or delayed.
Delayed or inaccurate test results could harm patients awaiting treatment decisions, particularly for time-sensitive tests like troponin used in acute cardiac care. Beckman Coulter identified the issue on February 29, 2024, during manufacturing inspection. Affected facilities should contact Beckman Coulter for guidance on identifying their instruments and corrective actions.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human…
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 9
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 (10)
- UDI/DI 15099590732103
- Serial Numbers: 300273
- 300275
- 300276
- 300277
- 300281
- 300282
- 300284
- 300286
- 300297
Distribution
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