The Recall Desk
HighFDA (Devices)·Z-1077-2019·Announced 2019-04-10

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.

What this means for you

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.
Category
Medical Device — Laboratory Equipment
Hazard
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

Distributed in 26 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.

See all 2 products in this recall →

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