Beckman Coulter DxI 9000 Access analyzer software causes delayed test results
Beckman Coulter has recalled 183 DxI 9000 Access analyzers due to a software issue that causes delays in test result reporting. When connected to a Laboratory Automation System, software versions 1.17 and below send out-of-sequence messages, potentially delaying patient treatment.
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: FDA Class II device with no reported illnesses or hospitalizations. The software defect creates a risk of delays in patient test result reporting, matching the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling 183 DxI 9000 Access Immunoassay Analyzer devices. The recalled units are running software versions 1.17 and below.
When a DxI 9000 analyzer is connected to a Laboratory Automation System and operating on the affected software versions, the analyzer sends out-of-sequence messages back to the automation system. These messages trigger error displays on the connected system, such as sample pick-and-place errors or "no result obtained" flags. As a result, there is a risk of delays in processing and reporting patient test results, potentially delaying patient treatment.
The recalled devices have been distributed worldwide, including in the United States (California, Florida, Georgia, Indiana, Kansas, Maine, New Hampshire, New Jersey, Oklahoma, Pennsylvania, and Texas) and internationally in Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
The recalled product
- Product
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 183
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 (2)
- Software versions 1.17 and below
- UDI-DI 15099590732103.
Distribution
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