Beckman Coulter DxA Automation System software defect may produce erroneous patient test results
A software defect in the Beckman Coulter DxA Automation System may cause tests to be performed on incompatible tube types, potentially producing inaccurate patient results. Affected systems were distributed in the US and internationally.
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 recall involves a Class II medical device with a software defect that could produce erroneous patient test results. No illnesses or injuries have been reported, meeting the criterion for a risk-of-harm product where the hazard is theoretical rather than realized.
Plain-English summary
Beckman Coulter is recalling the DxA Automation System (model DxA 5000, REF: B87352), a clinical laboratory automation system used for processing patient test samples. Approximately 146 units have been distributed worldwide.
A software defect in the system may cause clinical tests to be run on patient samples in tube types that are not compatible with the requested test. This incompatibility can result in erroneous test results that do not accurately reflect the patient's sample.
The affected systems were distributed to healthcare facilities in 19 US states: Alabama, California, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Wisconsin, and West Virginia. Additional units were distributed to 24 countries outside the US.
Healthcare facilities using this system should contact Beckman Coulter Biomedical GmbH for remediation guidance. All DxA systems (all serial numbers) are potentially affected by this software defect.
The recalled product
- Product
- Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- Manufacturer
- Beckman Coulter Biomedical GmbH
- Hazard
- software-defect
- erroneous-test-results
- sample-mismatch
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)
- UDI-DI: (01)15099590707118
- All DxA serial numbers
Distribution
Distributed in 19 states:
- AL
- CA
- FL
- IL
- IN
- KY
- MI
- MN
- MO
- NE
- NJ
- NV
- NY
- OH
- PA
- SC
- TX
- WI
- WV
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