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.
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: 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 bod
- 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
Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighBeckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
FDA (Devices) · 2026-04-29
Same hazard · erroneous results
See all →- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
- HighBlood tubes recalled after being manufactured without the gel separator
FDA (Devices) · 2025-11-26