Beckman Coulter Analyzer May Fail to Restart After Shutdown
Beckman Coulter's UniCel DxL 600 analyzer may fail to restart after shutdown due to a communication issue, preventing sample processing and causing delayed results. 1,272 units recalled worldwide.
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: This is an FDA Class II medical device recall with no reported adverse events, hospitalizations, or injuries. The issue is a functional communication failure preventing device startup and operation, causing operational delays and delayed diagnostic results, but not direct reported patient harm.
Plain-English summary
Beckman Coulter, Inc. is recalling 1,272 units of the UniCel DxL 600 analyzer (part numbers A71460, A71461, A30260) used for immunoassay testing of Troponin Subunit levels.
Due to a potential communication issue, the affected analyzers may not successfully restart following a standard shutdown, even after multiple attempts. When this occurs, the instrument cannot initialize or transition to Ready mode.
When unable to restart, the analyzer cannot process patient samples, quality control materials, or calibrators, resulting in delayed diagnostic results.
The devices have been distributed nationwide in the United States and internationally to countries worldwide.
The recalled product
- Product
- Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device
- Hazard
- startup-failure
- delayed-results
Distribution
Distributed nationwide across the United States.
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