Medical Analyzer May Fail to Restart After Shutdown, Delaying Patient Results
Beckman Coulter UniCel Dxl 800 analyzers may fail to restart following standard shutdown due to a communication issue. When this occurs, units cannot process patient samples, resulting in delayed test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a functional communication failure causing operational delays rather than a reported safety defect or direct patient harm.
Plain-English summary
The Beckman Coulter UniCel Dxl 800 clinical analyzer, used for immunoassay testing including troponin subunit analysis, is affected by a potential communication issue. Approximately 6,457 units of this analyzer have been distributed worldwide.
A communication issue may prevent the analyzer from successfully restarting after a standard shutdown, even after multiple restart attempts. If this occurs, the instrument cannot complete initialization or transition to Ready mode, making it unable to process patient samples, quality control samples, or calibrators.
As a result of this failure, patient test results are delayed. The affected units have been distributed throughout the US and to numerous countries internationally.
The recalled product
- Product
- Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- communication-failure
- delayed-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 (4)
- 973100: UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou)
- A71456: UDI 15099590369194
- A71457: UDI 15099590369231
- A25288: UDI 15099590194819
Distribution
Distributed nationwide across the United States.
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