Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error
Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect 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 involves a risk-of-harm product (medical device) where incorrect test results could lead to patient harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Beckman Coulter Inc. is recalling UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems. The recall applies to systems that have been re-configured so that the DxI system is separated from the DxC system and the DxI instrument is connected to an automation line. The affected systems are running software versions 5.2, 5.3.0, or 5.3.1.
The recall is due to a scheduling error within the software that can occur when racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed. This error can cause mishandling of samples during the creation of an aliquot, leading to incorrect results. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, though the potential for falsely elevated results cannot be ruled out.
The affected units are distributed in the United States and various international locations. Healthcare facilities using these specific re-configured systems should contact Beckman Coulter for further instructions on resolving the software issue.
The recalled product
- Product
- UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i…
- 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 (3)
- Systems running software versions: 5.2
- 5.3.0
- 5.3.1.
Distribution
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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