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.
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: 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.
- Affected units
- 116
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.
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