Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error
Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay 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 the hazard involves incorrect diagnostic results which can lead to misdiagnosis or inappropriate treatment, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxI 600 and 800 Access Immunoassay Systems that are connected to an automation line. The recall involves 2,842 units distributed across 26 U.S. states and 30 countries. The affected systems are running software versions 5.2, 5.3.0, or 5.3.1.
The recall is due to a software scheduling error 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 aliquot creation, leading to incorrect results. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, though falsely elevated results are also possible.
Healthcare facilities using these systems should contact Beckman Coulter for instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,842
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 (2)
- Systems running software versions: 5.2
- 5.3.0
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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