DxI 800 immunoassay analyzers recalled over a failure to restart after shutdown
Beckman Coulter is recalling 6,457 UniCel DxI 800 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed 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: Scored 2 because the record's stated consequence is delayed results, with no erroneous results or reported harm.
Plain-English summary
The Beckman Coulter UniCel DxI 800, part numbers 973100, A71456, A71457 and A25288, an immunoassay analyzer, is being recalled.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers 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 will not process patient samples, quality controls or calibrators, which the firm states causes delayed results.
The record lists 6,457 units, with UDIs including 15099590265373 and 16954701000412 for part 973100 and 15099590369194 for part A71456. Distribution was worldwide, including nationwide in the United States and to a wide range of other countries. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should follow Beckman Coulter's instructions.
The recalled product
- Product
- Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 6,457
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.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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