DxI 600 immunoassay analyzers recalled over a failure to restart after shutdown
Beckman Coulter is recalling 1,272 UniCel DxI 600 analyzers because a potential communication issue may prevent the instrument restarting after a standard shutdown, causing delayed results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 600, part numbers A71460, A71461 and A30260, 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 1,272 units, carrying UDIs 15099590369224, 15099590369248 and 15099590341602. 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 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 1,272
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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