Laboratory Analyzer Software Bug Could Produce Erroneous Clinical Test Results
Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.
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 is a Class II medical device recall involving software bugs that could cause erroneous clinical laboratory results. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Beckman Coulter, Inc. is recalling 128 DxI 9000 Access Immunoassay Analyzer units running software version 1.16 or earlier. These analyzers are used in clinical laboratories to measure hormone and drug levels in patient samples.
Four software bugs have been identified that could cause the analyzer to produce erroneous results or delay result reporting: (1) incorrect conversion factor applied when insulin measurements are configured in SI units (pmol/L); (2) numerical results reported below the lowest valid measurement range when non-default units are used; (3) a result of 0 incorrectly displayed when calculated results use non-numerical symbols such as > or <; and (4) mismatched assay coding when reserve volume is enabled and the LIS code differs from the Test ID.
The affected analyzers are distributed worldwide, including throughout the United States and in Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Healthcare facilities using affected analyzers should verify their device serial numbers against the recall list and contact Beckman Coulter for remediation instructions.
The recalled product
- Product
- DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 128
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 15099590732103
- Serial Numbers: 300116
- 300117
- 300118
- 300123
- 300127
- 300126
- 300128
- 300129
- 300130
- 300131
- 300133
- 300134
- 300135
- 300136
- 300138
- 300139
- 300137
- 300140
- 300142
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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