Beckman Coulter Unicel Dxl 800, Part Numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter is recalling certain UniCel Dxl 800 analyzers (part numbers 973100, A71456, A71457, A25288) used for troponin testing because of a communication problem that may prevent the machines from restarting properly. When this happens, the analyzer cannot initialize or process patient samples, leading to delayed test results. The recall affects healthcare facilities using these specific analyzer models.
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
- Reason
- Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
- Classification
- Class I
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-11-26
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2a5c846d-6bc9-46a6-8106-9f6b28495b5a