Immunoassay Analyzer Software Defect May Cause Incorrect Test Calibration
Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.
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: This FDA Class II medical device contains a software defect that creates a risk of erroneous diagnostic results. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products without reported patient injury are scored at 3 (High).
Plain-English summary
Beckman Coulter is recalling 116 DxI 9000 Access Immunoassay Analyzers worldwide. These in-vitro diagnostic devices measure various substances in blood and other body fluids.
The recall is due to a software defect in calibrator validation. When an operator configures a new calibrator lot, the analyzer accepts calibrator values from any scanned calibrator card, regardless of test code or material lot number. It fails to verify that all barcodes come from the same calibrator card. This can cause an incorrect calibration curve, potentially resulting in erroneous or delayed patient test results.
The defect affects all software versions and all DxI 9000 instruments currently in the field. Calibrator materials with 2D barcodes are not affected by this issue.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- calibration-error
- erroneous-results
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
- 300123
- 300124
- 300126
- 300128
- 300129
- 300130
- 300131
- 300133
- 300134
- 300135
- 300136
- 300137
- 300138
- 300139
- 300141
- 300142
- 300143
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03