Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay 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 involves a risk-of-harm product (medical diagnostic device) where erroneous results could lead to incorrect medical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling UniCel DxI 600 Access Immunoassay Systems, part numbers A30260 and A71460. The recall was initiated after the company received seven reports of a software anomaly affecting the devices. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
The software anomaly may cause erroneous test results if it goes undetected. A total of 2,442 units were distributed worldwide, including 784 units in the United States. The devices were distributed nationwide in the US and in numerous other countries, including Canada, Mexico, Australia, and various nations in Europe, Asia, and Africa.
Healthcare facilities and users of these devices should contact Beckman Coulter for further instructions on how to address the software anomaly and ensure accurate diagnostic results.
The recalled product
- Product
- UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations…
- 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 (2)
- Part Numbers: Dxl 600: A30260
- Dxl 600 with spot B: A71460.
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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