Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i systems because a software anomaly may cause erroneous test 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of erroneous test results, which fits the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems. These are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. The recall involves 2,442 units total, with 784 units distributed in the United States and the remainder distributed worldwide.
The recall was initiated after Beckman Coulter received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. The affected part numbers are A64871 (DxC 660i), A64903 (DxC 680i), A64935 (DxC 860i), and A59102 (DxC 880i).
The FDA has classified this as a Class II recall. Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software anomaly and ensure accurate test results.
The recalled product
- Product
- UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or…
- Manufacturer
- Beckman Coulter Inc.
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)
- Part Numbers: DxC 660i: A64871
- DxC 680i: A64903
- DxC 860i: A64935
- DxC 880i: A59102
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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